200 results found for ''

Tracy A Kimmel

Tracy A. Kimmel, PhD, DABT Senior Manager of Toxicology, Eastern Operations tracy.kimmel@safebridge.com Dr. Kimmel is currently Senior Manager of Toxicology, Eastern Operations for SafeBridge Consultants, Inc. She has almost 20 years’ experience in the pharmaceutical industry, where she worked in v

Hilary Stinnett

Hilary Stinnett, PhD Associate Toxicologist Hilary.Stinnett@safebridge.com Dr. Hilary Stinnett is an Associate Toxicologist for SafeBridge Consultants, Inc. She has 5 years’ experience in non-clinical pharmaceutical research, with expertise in molecular biology and a wide variety of in vivo and i

Elizabeth M Vancza

Elizabeth M. Vancza, PhD, DABT Toxicologist, Eastern Operations elizabeth.vancza@safebridge.com Dr. Elizabeth Vancza has extensive knowledge in toxicology, risk assessment, and environmental health and safety, in particular the evaluation of complex environmental health and safety issues, and the d

Erica L Dahl

Erica L. Dahl, PhD, DABT Senior Toxicologist, Eastern Operations erica.dahl@safebridge.com Dr. Dahl is a senior toxicologist with over 10 years of experience in toxicology, with expertise in molecular biology, in vitro and alternative methods for toxicity testing and genotoxicity. Classes of agents

Vincent P Ramirez

Vincent P. Ramirez, PhD Associate Toxicologist vincent.ramirez@safebridge.com   Molecular toxicology and pharmacology Occupational toxicology Risk assessment

Julia Abramov

Julia Abramov, PH.D. Toxicologist julia.abramov@safebridge.com  

Michael J. Olson, Ph.D., Fellow ATS Senior

Michael J. Olson, Ph.D., Fellow ATS Senior Manager of Environmental Health Services michael.olson@safebridge.com (919)-462-9693 Dr. Olson is Senior Manager of Environmental Health Services for SafeBridge Consultants, Inc. and has over 30 years’ experience as a toxicologist including 21 years specifi

Brent A Altemose

Brent A. Altemose, PhD, CIH, CSP Principal Industrial Hygienist brent.altemose@safebridge.com   Comprehensive industrial hygiene Industrial and laboratory ventilation Potent compound containment Indoor air quality Hazard and control banding Industrial safety

Yana Chervona

Yana Chervona, MPH, PhD Associate Toxicologist yana.chervona.@safebridge.com   Molecular toxicology Occupational toxicology Risk assessment

Robert G Sussman

Robert G. Sussman, PhD, DABT Principal Toxicologist and Managing Principal, Eastern Operations robert.sussman@safebridge.com Dr. Sussman is currently Managing Principal, Eastern Operations for SafeBridge Consultants, Inc. He has over 25 years experience in the pharmaceutical industry where he worked

Allan W Ader

Allan W. Ader, PhD, DABT Vice President and Principal Toxicologist allan.ader@safebridge.com Dr. Allan Ader has over 20 years experience in toxicology, risk assessment and industrial hygiene. He has an extensive background in evaluating complex environmental, health and safety issues and in developi

Staff

Project Management John P Farris Robert G Sussman Justin Mason-Home Toxicology Allan W Ader Erica L Dahl Yana Chervona Tracy A Kimmel Elizabeth M Vancza Vincent P Ramirez Industrial (Occupational) Hygiene Martin Axon Edward J Haggerty Jeff R Sc

Janet Gould

Janet Gould, Ph.D., DABT, CIH Senior Managing Toxicologist janet.gould@safebridge.com Janet has over 20 years of toxicology experience including 14 years in the pharmaceutical industry.  At Bristol-Myers Squibb, she headed up the Occupational Toxicology group where she was responsible for setting Oc

Jenny Llanera-Cadiz

Jenny Llanera-Cadiz Administrative Assitant jenny.llanera-cadiz@safebridge.com  

Debbie Keys

Debbie Keys Manager, Industrial Hygiene debbie.keys@safebridge.com   Debbie Keys, CIH, CHMM has over 30 years of comprehensive industrial hygiene experience, with a focus on pharmaceutical research & development and manufacturing, including 20 years at Syntex/Roche.  Her first role in the pharm

Stephen Nowakowski

Stephen Nowakowski Industrial Hygiene & Safety Consultant stephen.nowakowski@safebridge.com Stephen Nowakowski is an Industrial Hygiene and Safety Consultant for SafeBridge Consultants, Inc., Eastern Operations, based out of the Exton, PA office. His duties include industrial hygiene exposure a

Shalini Burra

Shalini Burra, M.S. Chemist II shalini.burra@safebridge.com Shalini Burra, M.S. started working for us in mid-March as a Chemist II.  Shalini has five years of experience and most recently worked for CS Bio, a peptide synthesis contract manufacturing organization.  She has also worked for Eurofins L

Sarah Lee

Sarah Lee, Ph.D. Chemist sarah.lee@safebridge.com Dr. Lee is a chemist for SafeBridge Consultants, Inc. She has over 9 year of experience with mass spectrometry method development for small and large molecules. Prior to joining Safebridge Consultants, she was at Bayer Healthcare and Johnson and Joh

Kent Rader

Kent Rader Manager, Analytical Laboratory Business Development kent.rader@safebridge.com Kent Rader is the Manager of Analytical Laboratory Business Development with SafeBridge Consultants, Inc.  His professional expertise is in laboratory operations, quality assurance, method development and busin

NEIHce Annual Meeting

CPhI North America 2017-05-16 2017-05-18 Philadelphia, Pennsylvania 2916

Catherine Connor

Catherine Conner Business Development Assistant catherine.connor@safebridge.com  

Chris Seaman

Chris Seaman, CBio, ERT Managing Toxicologist chris.seaman@safebridge.com  

Mark Forster, LFOH

Mark Forster, LFOH Occupational Hygienist Mark.Forster@safebridge.com 44 01543-579200 After attaining a BSc (Hons) in Biological Sciences, Mr Forster began his professional career working as an Environmental Health Technician for the Royal Air Force.  As part of his initial training he st

Natalia A Tsekhanovskaya

Natalia A. Tsekhanovskaya, PhD Natalia A. Tsekhanovskaya, PhD natalia@safebridge.com Dr. Tsekhanovskaya has over 20 years of biochemistry research experience. She has been responsible for development and validation of bioanalytical methods including immunoassays (radioimmunoassays - RIA - and enzyme-

Jennifer Nguyen

Jennifer Nguyen Chemist jennifer.nguyen@safebridge.com   Analytical method development and validation Sample analysis of airborne pharmaceutical products

Akash C Solanki

Akash C. Solanki Occupational Health & Safety Specialist, Eastern Operations akash.solanki@safebridge.com Mr. Solanki is an Occupational Health & Safety Specialist for SafeBridge Consultants, Inc., Eastern Operations. His duties include industrial hygiene occupational exposure assessments,

Gail Baer

Gail Baer Assistant Office Manager gail.baer@safebridge.com   Technical administrative support Accounting business systems Coordination of laboratory support

Susan Custer

Susan Custer Office Manager susan.custer@safebridge.com   Technical administrative support Accounting business systems Coordination of laboratory support

Karuna Sachdeva

Karuna Sachdeva, Ph.D., DABT Senior Toxicologist karuna.sachdeva@safebridge.com Karuna Sachdeva, Ph.D., DABT has over 10 years of experience in the areas of regulatory toxicology, impurities assessments and non-clinical toxicology testing and evaluation. She has contributed to the design of several

Lillian C. Fry, ASP

Lillian C. Fry, ASP Industrial Hygiene and Safety Associate lillian.fry@safebridge.com (610) 280-3902 X310   Industrial Hygiene OSHA Compliance Associate Safety Professional (ASP)

Charlyn Reihman

Charlyn Reihman Industrial Hygiene & Safety Associate charlyn.reihman@safebridge.com   Principal Occupational Health Consultant

Edward J Haggerty

Edward J. Haggerty, CIH Manager, Industrial Hygiene & Safety Services ed.haggerty@safebridge.com Mr. Haggerty has over 23 years of experience in comprehensive industrial hygiene, safety and environmental compliance. He has managed environmental health and safety programs in the electronic and sem

Jeff R Scott

Jeff R. Scott, MPH Industrial Hygiene & Safety Specialist jeff.scott@safebridge.com Jeff Scott has participated in risk assessment, toxicology, and industrial hygiene projects over the past ten years, serving as a consultant to the biotech, pharmaceutical, and semiconductor industries. These pro

Michael C Perry

Michael C. Perry, CMFOH Senior Occupational Hygienist, European Operations mike.perry@safebridge.com Mr. Perry began his professional career working as an occupational hygiene consultant for Sypol Environmental Management Limited. Here he gained considerable experience within a wide range of workpla

Martin Axon

Martin Axon, CFFOH, CMIOSH Principal Occupational Hygienist, European Operations martin.axon@safebridge.com Mr. Axon started his career as a site occupational hygienist for Syntex Pharmaceutical where he developed systems and methods to assess and reduce exposure to active pharmaceutical materials.

Stephen Woodcock

Stephen Woodcock BSc, PGDip Sci Senior Chemist steve.woodcock@safebridge.com Steve Woodcock has over 16 years of experience in regulated biopharmaceutical and Contract Research Organizations (CRO) and has been responsible for development and validation of bioanalytical methods including immunoassays

Helen Felton

Helen Felton Office Manager, European Operations helen.felton@safebridge.com   Technical administrative support Accounting

Online Access to Industrial Hygiene Analytical Services

Online Access to Industrial Hygiene Analytical Services 2016-03-23 SafeBridge Consultants, Inc., (SafeBridge) the premier resource to the pharmaceutical and biotechnology industry in potent compound safety and product safety support, announces the online availability of air and surface sample analysis capabili

SafeBridge Consultants Announces New Leadership Appointments

SafeBridge Consultants Announces New Leadership Appointments 2017-01-09 SafeBridge Consultants, a Trinity Consultants company and premier occupational health and safety consulting firm to the pharmaceutical, biotechnology, and fine chemical industry, announced today that Allan Ader, PhD, DABT and Robert Sussma

Navigating OSHAs Respirable Crystalline Silica Rule

Pre-Recorded Webinar: Navigating OSHA’s Respirable Crystalline Silica Rule On March 24, 2016, the Occupational Safety and Health Administration (OSHA) finalized its existing standards for occupational exposure to respirable crystalline silica. OSHA has determined that employees exposed to respirable crystalli

Careers

Careers SafeBridge Consultants, Inc. (SafeBridge) is the premier and branded resource to the pharmaceutical and biotechnology industry in occupational health and safety. SafeBridge has provided the "Potent Compound Safety Triangle" of services in industrial hygiene, risk assessment, occupational toxicology,

EHS

 

Notify Me Thank You

Training Waiting List Thank you for your submission You will be contacted if there is a cancellation and when the next training dates are scheduled. Return to the Home Page

Risk Assessment and Control of Antibody-Drug Conjugates

Northeast Industrial Hygiene Conference: Risk Assessment and Control of Antibody-Drug Conjugates 2016-12-02 On Friday December 2, 2016,  Robert Sussman, Ph.D., DABT and Charlyn Reihman MPH, CIH, presented “Risk Assessment and Control of Antibody-Drug Conjugates”   at the Northeast Industrial Hygiene Confere

Laboratory Animal Allergen Control

Laboratory Animal Allergen Control SafeBridge provides Laboratory Animal Allergen (LAA) occupational health services designed to assist clients in the prevention of health effects as a result of exposure to laboratory animal allergens. Approximately 30 percent of people who work with

SafeBridge Announces TWO New Courses

SafeBridge Announces TWO New Courses 2017-04-14 SafeBridge Consultants: Industrial Hygiene in the Pharmaceutical Industry July 11-12, 2017, Oakbrook Terrace, IL   SafeBridge has developed a new 1.5 day course to provide health and safety professionals from a range of disciplines with the too

Accredited Laboratory Services

Accredited Analytical Laboratory Services The SafeBridge industrial hygiene laboratory develops analytical methods to help the pharmaceutical and biotechnology industry meet their workplace air monitoring and surface sampling requirements. We are accredited by the American Industrial Hygiene Association Laboratory Accreditation

San Francisco

San Francisco Office 1924 Old Middlefield Way Mountain View CA 94043-2503 us (650) 961-4820 (650) 623-0096

New York

SafeBridge Consultants, Inc. Eastern Operations New York Office 330 Seventh Avenue, Suite 2001 New York NY 10001 us (212) 727-0717 (646) 304-2700

Europe

SafeBridge Europe, Limited Liverpool Science Park United Kingdom Office 131 Mount Pleasant Liverpool L3 STF gb +44 (0) 151 294 3174 +44 (0) 151 294 3176

Developing Acceptable Surface Limits for Occupational Exposure to Pharmaceutical Substances

Developing Acceptable Surface Limits for Occupational Exposure to Pharmaceutical Substances 2016-09-01 Authors: Tracy A. Kimmel, Ph.D., DABT, Robert G. Sussman, Ph.D., DABT, Robert H. Ku, Ph.D., DABT, CIH, and Allan W. Ader, Ph.D., DABT

The Evaluation of Safe Handling of ADCS and their Toxic Payloads Part 2

The Evaluation of Safe Handling of ADCS and their Toxic Payloads: Part 2 2016-07-01 Published in the July 2016 issue of Cleanroom Technology. Authors: John Farris, CIH and Robert Sussman, PhD DABT The Evaluation of Safe Handling of ADCS and their Toxic Payloads Part 2

IH Statistics The Next Generation

IH Statistics The Next Generation 2016-04-28 Author: Brent Altemose, PhD, CIH, CSP, Principal Hygienist. Presented at the Occupational Hygiene 2016 conference in Glasgow, Scotland. IH Statistics The Next Generation

Quantification of Free Drug and Antibody Drug Conjugate Compounds Collected During Industrial Hygiene Surface Monitoring Procedures

Quantification of Free Drug & Antibody Drug Conjugate (ADC) Compounds Collected During Industrial Hygiene (IH) Surface Monitoring Procedures 2016-05-23 Authors: Natalia Tsekhanovskaya, Ph.D.; Stephen Woodcock, B.S., PGDip Sci; Teresa Bryning, M.S. Quantification of Free Drug and Antibody Drug Conjug

The Evaluation and Safe Handling of ADCS and their Toxic Payloads Part 1

The Evaluation and Safe Handling of ADCS and their Toxic Payloads: Part 1 2016-06-01 Published in the June 2016 issue of Cleanroom Technology . Authors: John Farris, CIH and Robert Sussman, PhD DABT The Evaluation and Safe Handling of ADCS and their Toxic Payloads Part 1

Assessing Risk and Controlling Exposure to Potent Compounds During Pharmaceutical Packaging

Assessing Risk and Controlling Exposure to Potent Compounds During Pharmaceutical Packaging 2010-05-01 Published in the May 2010 issue of Tablets & Capsules . Author: John P. Farris, CIH, CEO and President Assessing Risk and Controlling Exposure to Potent Compounds During Pharmaceutical Packaging

Contained Chemistry Synthesizing Highly Potent Compounds is a Lucrative and Growing Niche for Custom Chemical Manufacturers

Contained Chemistry – Synthesizing Highly Potent Compounds is a Lucrative and Growing Niche for Custom Chemical Manufacturers 2008-06-18 Published in Chemical & Engineering News , Vol 86 No 24. Cover story featuring John Farris, CEO and President. Contained Chemistry – Synthesizing Highly Potent Comp

Applying Health-Based Risk Assessments to Worker and Product Safety for Potent Pharmaceuticals in Contract Manufacturing Operations

Applying Health-Based Risk Assessments to Worker and Product Safety for Potent Pharmaceuticals in Contract Manufacturing Operations 2009-07-01 Published in Pharmaceutical Outsourcing in the July/August 2009 issue. Authors: Allan W. Ader, Ph.D., DABT - Vice President and Principal Toxicologist; Tracy A. Kim

Assessing Drug Substances to Identify Highly Hazardous Compounds for Quality Risk Management Programs

Assessing Drug Substances to Identify “Highly Hazardous” Compounds for Quality Risk Management Programs Assessing Drug Substances to Identify “Highly Hazardous” Compounds for Quality Risk Management Programs

Handling Highly Potent Active Pharmaceutical Ingredients Equipment Containment Performance

Handling Highly Potent Active Pharmaceutical Ingredients – Equipment Containment Performance 2008-03-01 Published in Chemistry Today , Vol 26 No 2, March/April 2008. Authors: Martin W. Axon, John P. Farris, and Justin Mason Handling Highly Potent Active Pharmaceutical Ingredients – Equipment Containment

Developing Occupational Exposure Limits for Pharmaceutical Substances

Developing Occupational Exposure Limits (OELs) for Pharmaceutical Substances Author: Allan W. Ader, Ph.D., DABT, Principal Toxicologist Developing Occupational Exposure Limits (OELs) for Pharmaceutical Substances

A Process Hazard Analysis Concept for Pharmaceutical Operations

A Process Hazard Analysis Concept for Pharmaceutical Operations A Process Hazard Analysis Concept for Pharmaceutical Operations

An Overview of Setting Occupational Exposure Limits for Pharmaceuticals

An Overview of Setting Occupational Exposure Limits (OELs) for Pharmaceuticals 2000-01-01 Published in Chemical Health & Safety , January/February 2000. Authored by Robert H. Ku, Ph.D., CIH, Principal Toxicologist. An Overview of Setting Occupational Exposure Limits (OELs) for Pharmaceuticals

Approaches to Fate and Effects Testing of Active Pharmaceutical Ingredients

Approaches to Fate and Effects Testing of Active Pharmaceutical Ingredients Author: Allan W. Ader, Ph.D., DABT, Principal Toxicologist Approaches to Fate and Effects Testing of Active Pharmaceutical Ingredients

Guidelines for Air Sampling Analytical Method Development Validation

Guidelines for Air Sampling Analytical Method Development Validation Author: Teresa Bryning, M.S. Guidelines for Air Sampling Analytical Method Development Validation

History Implementation and Evolution of the Pharmaceutical Hazard Categorization and Control Systems

History, Implementation and Evolution of the Pharmaceutical Hazard Categorization and Control Systems 2006-03-01 Published in Chemistry Today , Vol. 24. Authors: John P. Farris, Allan W. Ader, and Robert H. Ku. History, Implementation and Evolution of the Pharmaceutical Hazard Categorization an

Important Elements in Evaluating contract Manufacturing Organizations

Important Elements in Evaluating contract Manufacturing Organizations 2007-04-01 Published in Chemistry Today , Vol 25, March/April 2007. Authors: Allan W. Ader, J. Justin Mason, John P. Farris Important Elements in Evaluating contract Manufacturing Organizations

Industrial Hygiene Control Program Elements In Pharmaceutical Operations

Industrial Hygiene Control Program Elements In Pharmaceutical Operations Author: John P. Farris, CIH, President and Managing Principal Industrial Hygiene Control Program Elements In Pharmaceutical Operations

Manufacturing Highly Potent Drugs Reducing the Risks

Manufacturing Highly Potent Drugs: Reducing the Risks John Farris, president and managing principal, SafeBridge Consultants, discusses the key elements and issues surrounding the manufacturing of highly potent active ingredients issue with Pharmaceutical Visions consulting editor Mark Greener. Manufac

Occupational Health Categorization and Compound Handling Practice Systems Roots Applications and Future

Occupational Health Categorization and Compound Handling Practice Systems - Roots, Applications and Future 2005-07-01 Published in Chemical Health & Safety , July/August 2005. Authors: Allan W. Ader, PhD, DABT; John P. Farris, BS, CIH; and Robert H. Ku, PhD, DABT Occupational Health Categorizat

Procedures for Determining an Acceptable Daily Exposure under Risk-MaPP

Procedures for Determining an Acceptable Daily Exposure (ADE) under Risk-MaPP: Approaches for Developing and Documenting Acceptable Limits for Product Cross-Contamination Purposes 2010-10-20 Authors: Allan W. Ader, Robert G. Sussman, Tracy A. Kimmel, and Robert H. Ku Procedures for Determining an Acceptabl

Steps to Investigating Occupational Disease Incidents Involving Potent Compound Exposures

Steps to Investigating Occupational Disease Incidents Involving “Potent Compound” Exposures Author: John Farris, CIH, President and Managing Principal Steps to Investigating Occupational Disease Incidents Involving “Potent Compound” Exposures

Hiring Industrial Hygienist

Hiring Industrial Hygienist – Apply Today! 2016-08-17 Join our high performing team of experienced consultants serving the occupational and environmental health and product safety needs of pharmaceutical, chemical and biotechnology companies across the country and internationally. With offices located in Mount

Leadership Transition at SafeBridge Consultants

Leadership Transition at SafeBridge Consultants 2015-10-15 Effective immediately, founding President and CEO, John Farris, will step down from his leadership role in the company in order pursue the next phase of his life and career. John will continue to be associated with the firm in a limited role as a consu

SafeBridge Potent Compound Safety Certification Program Update

SafeBridge Potent Compound Safety Certification Program Update 2015-07-22 SafeBridge Consultants, Inc. (SafeBridge) has issued an updated status of their ground-breaking program to assist pharmaceutical and biotechnology companies in identifying contract manufacturing organizations qualified in the safe hand

An In-Depth Interview with SafeBridge President and CEO John Farris by SAFC Live

An In-Depth Interview with SafeBridge President and CEO, John Farris by SAFC Live 2011-11-07 John Farris was recently interviewed for SAFC Live on the SafeBridge Certification process. "An In-Depth Interview with SafeBridge President and CEO, John Farris" SAFC’s Verona plant has just been awarded SafeBridge Ce

Workshop on the Impact of REACH and CLP Regulations on Companies Exporting Chemicals to the EU presented in Partnership with H2 Compliance

Workshop on the Impact of REACH and CLP Regulations on Companies Exporting Chemicals to the EU presented in partnership with H2 Compliance on December 7, 2010 in New Brunswick, NJ 2010-11-01 Workshop on the Impact of REACH and CLP Regulations on Companies Exporting Chemicals to the EU presented in partnership

John Farris and Robert Sussman Quoted in Pharmaceutical Technology Article on High Potency Manufacturing

John Farris and Robert Sussman Quoted in Pharmaceutical Technology Article on High Potency Manufacturing

Chemistry Today Important Elements in Evaluating Contract Manufacturing Organizations

Chemistry Today - Important Elements in Evaluating Contract Manufacturing Organizations

Applying Health-Based Risk Assessments to Worker and Product Safety for Potent Pharmaceuticals in Contract Manufacturing Operations

July-Aug: Pharmaceutical Outsourcing - Applying Health-Based Risk Assessments to Worker and Product Safety for Potent Pharmaceuticals in Contract Manufacturing Operations - Allan Ader, Tracy Kimmel, Robert Sussman 2009-07-01 July-Aug: Pharmaceutical Outsourcing - Applying Health-Based Risk Assessments to Worker

SafeBridge Consultants Announces Potent Compound Safety Certification Approval for AMRI High Potency API Facilities in Rensselaer New York

SafeBridge Consultants, Inc. Announces “Potent Compound Safety Certification” Approval for AMRI High Potency API Facilities in Rensselaer, New York 2010-01-20 January 20, 2010 Mountain View, CA, U.S.A. SAFEBRIDGE® CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced

Assessing Risk and Controlling Exposure to Potent Compounds During Pharmaceutical Packaging

‘Assessing Risk and Controlling Exposure to Potent Compounds During Pharmaceutical Packaging’ article by John Farris, Tablets & Capules May 8, 2010 2010-05-28 ‘Assessing Risk and Controlling Exposure to Potent Compounds During Pharmaceutical Packaging’ article by John Farris, Tablets & Capules May 8,

SafeBridge Consultants Announces Development of Analysis for Lactose and Mannitol for Containment Performance Verification Studies

SafeBridge Consultants, Inc. Announces Development of Analysis for Lactose and Mannitol for Containment Performance Verification Studies 2011-05-11 May 11, 2011 Mountain View, CA, U.S.A. SAFEBRIDGE® CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced today that its

SafeBridge Consultants Announces Potent Compound Safety Certification Approval for Excella GmbH High Potency Oral Solid Dosage Form Facilities

SafeBridge Consultants, Inc. Announces “Potent Compound Safety Certification” Approval for Excella GmbH High Potency Oral Solid Dosage Form Facilities in Feucht, Germany 2011-03-01 March 1, 2011 Mountain View, CA, U.S.A. SAFEBRIDGE® CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, Califor

SafeBridge Consultants Announces Potent Compound Safety Certification Approval for Baxter Oncology GmbH Facilities in Halle and Bielefeld Germany

SafeBridge Consultants, Inc. Announces “Potent Compound Safety Certification” Approval for Baxter Oncology GmbH facilities in Halle and Bielefeld, Germany 2012-06-12 June 12, 2012 Mountain View, CA, U.S.A. SAFEBRIDGE® CONSULTANTS, INC. ("SafeBridge"), headquartered in Mountain View, California, has announ

SafeBridge Consultants Announces Potent Compound Safety Certification Approval for Excella GmbH API Plant Feucht Germany

SafeBridge Consultants, Inc. Announces “Potent Compound Safety Certification” Approval for Excella GmbH API Plant Feucht, Germany 2012-02-15 February 15, 2012 Mountain View, CA, U.S.A. SAFEBRIDGE® CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced that Excella GmbH

SafeBridge Consultants Announces Potent Compound Safety Certification Approval of Corden Pharma Colorado API Manufacturing Location

SafeBridge Consultants, Inc. Announces “Potent Compound Safety Certification” Approval of Corden Pharma Colorado API Manufacturing Location 2014-01-20 January 20, 2014 Mountain View, CA, U.S.A. SAFEBRIDGE® CONSULTANTS, INC. (SafeBridge) headquartered in Mountain View, California, has announced that Corden

SafeBridge Consultants Announces Potent Compound Safety Certification Approval of ScinoPharm Taiwan

SafeBridge Consultants, Inc. Announces “Potent Compound Safety Certification” Approval of ScinoPharm Taiwan, Ltd. 2009-11-19 November 19, 2009 Mountain View, CA, U.S.A. SAFEBRIDGE® CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced that ScinoPharm Taiwan Limited (

SafeBridge Consultants Announces Potent Compound Safety Certification Approval of DSM Pharmaceuticals Greenville North Carolina USA

SafeBridge Consultants, Inc. Announces “Potent Compound Safety Certification” Approval of DSM Pharmaceuticals, Inc., Greenville, North Carolina, USA 2009-08-03 August 3, 2009 - Mountain View, CA, U.S.A. SAFEBRIDGE CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced

SafeBridge Consultants Announces Potent Compound Safety Certification Approval of Lonza AG Visp Switzerland

SAFEBRIDGE CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California

SafeBridge Consultants Announces Availability of Computational Predictive Toxicology Capabilities

SafeBridge Consultants, Inc. Announces Availability of Computational Predictive Toxicology Capabilities 2014-01-07 January 7, 2014 Mountain View, CA, U.S.A. SAFEBRIDGE® CONSULTANTS, INC. ("SafeBridge"), a division of Trinity Consultants, Inc., Dallas, TX, with offices in Mountain View, CA, New York, NY, a

SABRE Health and Safety Merges with SafeBridge Consultants

SABRE Health & Safety, LLC merges with SafeBridge® Consultants, Inc. 2014-09-29 SAFEBRIDGE® CONSULTANTS, INC. ("SafeBridge"), headquartered in Mountain View, California, announced that SABRE Health & Safety, LLC ("SABRE") in Easton, Pennsylvania has joined SafeBridge as of September 29, 2014. SABR

SafeBridge Consultants Merges with Trinity Consultants

SafeBridge Consultants, Inc. (including its subsidiary SafeBridge Europe, Ltd.) has agreed to merge with Trinity Consultants, Inc. of Dallas, Texas 2012-12-17 SafeBridge Consultants, Inc. (including its subsidiary SafeBridge Europe, Ltd.) has agreed to merge with Trinity Consultants, Inc. of Dallas, Texas. Rea

SafeBridge Consultants Announces Potent Compound Safety Certification Approval of Ferro Pfanstiehl Laboratories Waukegan Illinois USA

SAFEBRIDGE CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California

SafeBridge Consultants Announces Potent Compound Safety Certification Approval of the SAFC Saint Louis Missouri USA facility

SAFEBRIDGE CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California

Dr Liz Vancza Joins SafeBridge Consultants as an Associate Toxicologist

Dr. Liz Vancza joins SafeBridge Consultants, Inc. as an Associate Toxicologist 2009-11-01 SafeBridge Consultants, Inc. employee announcement: Dr. Liz Vancza joins SafeBridge Consultants, Inc. as an Associate Toxicologist. Dr. Vancza recently successfully defended her Ph.D. thesis at New York University’s In

SafeBridge Consultants Announces Potent Compound Safety Certification Approval of Novasep

SafeBridge® Consultants, Inc. Announces “Potent Compound Safety Certification” Approval of Novasep – Le Mans (Seripharm), Inc. 2009-09-18 September 18, 2009 Mountain View, CA, U.S.A. SAFEBRIDGE® CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced that Novasep – Le

SafeBridge is Featured in the San Francisco Business Times

SafeBridge is featured in the San Francisco Business Times.

SafeBridge Consultants Laboratory Accredited by American Industrial Hygiene Association for Pharmaceutical Sample Analysis

SafeBridge Consultants, Inc. (SafeBridge) is pleased to announce the accreditation of its Mountain View...

SafeBridge Consultants Improved Sensitivity for the Analysis of Naproxen Sodium for Industrial Hygiene Containment Performance Verification

SafeBridge® Consultants, Inc. Announces Improved Sensitivity for the Analysis of Naproxen Sodium for Industrial Hygiene Containment Performance Verification and Surrogate Sampling Studies 2010-02-10 February 10, 2010 - Mountain View, CA, U.S.A. SAFEBRIDGE® CONSULTANTS, INC. (“SafeBridge”), headquartered i

Regulatory Services to Support CLP Regulations

Regulatory Services to Support CLP Regulations 2010-04-23 Regulatory Compliance Services Classification, Labeling and Packaging (“CLP”) and Safety Data Sheet (“SDS”) Support for Pharmaceutical and Other Chemicals Regulatory Deadline Approaching for CLP Compliance The EU classification, labeling

SafeBridge Europe is Moving

SafeBridge Europe is Moving 2011-08-17 SafeBridge Europe is moving “Due to our business growth and success over the past six years, SafeBridge Europe, Ltd. based in Liverpool, will be moving to a new location to accommodate our staff. This move provides SafeBridge Europe with additional space and convenience,

Technical Papers

Aenean at erat in nisl posuere sagittis at sit amet dui. Suspendisse dapibus felis at cursus mollis. Duis purus sem, molestie vitae hendrerit id, porta a erat. Morbi eget fermentum lorem. Duis quis fringilla tellus. Cras vehicula erat ac ex suscipit placerat. Ut vel ullamcorper nibh, venenatis eleifen

News

 

Events

 

The Evaluation of Safe Handling of ADCS and their Toxic Payloads Part 2

Facility features and controls Facility features can present a challenge depending on the other operations in a given facility. Where powders are handled and the primary concern is potential occupational exposure to extremely toxic materials one set of recommendations may apply. Once powders are in solution and antibod

The Evaluation and Safe Handling of ADCS and their Toxic Payloads Part 1

Fig. 1: Components of a typical ADC molecule The development of ADCs has provided a new technology platform for the treatment of various cancers and other diseases. In theory, ADCs allow for the targeted delivery of exquisitely potent materials to tumours and other diseased organs, without the concern for off-target to

Quantification of Free Drug and Antibody Drug Conjugate Compounds Collected During Industrial Hygiene Surface Monitoring Procedures

SA–HRP B Quantification of cDMx collected either by itself or together with DMx on the same swab, is performmed by Double –Antibody Sandwich ELISA: • ELISA microplate wells are coated with anti-human polyclonal antibody • Known amounts of cDMx from standards and from unknown samples are sandwiched between the immobiliz

IH Statistics The Next Generation

STATISTICSBrent Altemose, Ph.D., CIH, CSPPrincipal HygienistOccupational Hygiene 2016 –Glasgow, Scotland28 April 2016SafeBridge Consultants, Inc.A TRINITY CONSULTANTS COMPANYMountain View, CA ▪New York, NY ▪Liverpool, UK ▪Easton, PAwww.safebridge.comTHE NEXT GENERATIONIHWhere We Are TodayDespite advances, “professiona

Developing Acceptable Surface Limits for Occupational Exposure to Pharmaceutical Substances

Tracy A. Kimmel, Ph.D., DABT,1 Robert G. Sussman, Ph.D., DABT,1 Robert H. Ku, Ph.D., DABT, CIH,1 and Allan W. Ader, Ph.D., DABT1 Developing Acceptable Surface Limits for Occupational Exposure to Pharmaceutical Substances ABSTRACT: Acceptable surface limits (ASLs) are developed in order to establish a quantitative measu

Training Content Block

Home Page content block

Advanced Concepts in Potent Compounds (Boot Camp II)

(Boot Camp II) Advanced Concepts to Support Drug Development of Potent Compounds from R&D through Manufacturing SafeBridge Potent Compound Safety “Boot Camp II” A one-day advanced course with a focus on case studies and problem-solving to address potent compound safety issues in discovery, development, contract manufacturing and commercialization utilizing the “systematic” approach and the implementation of a comprehensive program required to successfully support drug R&D and manufacturing organizations. (Boot Camp II) SAFEBRIDGE® ADVANCED CONCEPTS IN POTENT COMPOUND SAFETY (BOOT CAMP II) SCHEDULE Day 1 Time Topics - A blend of lecture, exercises and scenarios 8:15 Introduction Overview of drug development process 8:30 Drug Discovery Drug discovery involves the creation of new chemical entities (NCEs) and new biological entities (NBEs) at the laboratory bench. NCEs and NBEs are handled in milligram to gram quantities with researchers working very close to their materials in work environments typified by standard control devices (lab hoods, biological safety cabinets) and limited personal protective equipment (lab coats, gloves, safety glasses). This module will examine: Evaluation of compounds based on the literature, experience, computer modeling and early testing; Identification of the unique risks of the research laboratory; and Selection and verification of effective control strategies.   10:15 Break 10:30 Drug Development –Early Stages NCEs and NBEs showing promise begin to be scaled up in kilo laboratories and drug product work begins in pre-formulation laboratories and formulation development suites. Pre-clinical data becomes available and small safety studies are initiated including Phase I safety and efficacy studies. Research and development staff may now be working with multi-gram and kilogram quantities of materials. It can be common that exposure controls are not much more advanced than those found in the discovery labs. Real risk management challenges are possible if the drugs are pharmacologically potent and toxic at levels found in these work environments. This module will examine: Evaluation of toxicity and clinical data; Evaluation of worker exposure at increasing scales of operation; Enhanced controls; and Development and effective use of IH data.   12:15 Lunch 1:00 Drug Development – Late Stages As drugs successfully move beyond basic demonstration of safety and efficacy in patient populations, broader studies are initiated requiring more drug substance and drug products manufactured in cGMP environments. Chemical pilot plants, clinical manufacturing suites and support laboratories are utilized at this stage. Small companies will engage contract manufacturing organizations (CMOs) and project management takes on increased importance. More pharmacology and toxicology data will become available which require prudent interpretation and utilization to assess potential workplace risk. Operations become more varied and control options are more numerous; however, the occupational health concerns have to be balanced with the requirements for product quality for the clinical materials manufactured. Preparations also begin for larger scale manufacturing including potential site selection in Phase III. This module will examine: Evaluation of more complex data; Application to quantitative risk assessment; and Implementation and demonstration of effective controls at larger scales.   2:30 Break 2:45 Commercial Scale Operations Sufficient data exist at the time of a New Drug Application to develop all the assessment tools required for scientific determination of safe operations including OELs, ASLs, ADIs and monitoring methods. Additionally the environmental aspects of a drug reaching this stage should have been studied and requirements for Environmental Assessments should have been met. CMOs should have been appropriately selected and in place as necessary along with any internal manufacturing sites. All control options are available in these manufacturing environments and selection of the best approaches must be balanced with productivity requirements. This module will examine: Application of defensible limits; Evaluation of CMOs; and The concept of product safe handling guidelines.   4:30 Wrap Up (Boot Camp II) What You’ll Learn in Advanced Concepts to Support Drug Development of Potent Compounds from R&D through Manufacturing: SafeBridge Potent Compound Safety “Boot Camp II” Data availability at each stage of the drug development process Containment and control, and handling guidelines for potent compounds at each scale of operation Problem solving using case studies in R&D and manufacturing of potent compounds Reviewing data obtained from occupational, non-clinical and clinical studies and industrial hygiene surveys and interpreting their applicability to case studies Potent compound safety issues with outsourcing as a paradigm for R&D and manufacturing of potent APIs and products And much more!

Potent Compound Safety (Boot Camp I)

(Boot Camp I) Potent Compound Safety “Boot Camp”® A comprehensive two-day course in pharmaceutical potent compound safety with a focus on training EH&S and related professionals in critical technical concepts and proactive safety programs in the pharmaceutical, chemical and biotechnology industries. (Boot Camp I) Potent Compound Safety "Boot Camp"® Schedule Day 1 Time Topics 7:45 – 8:15 Registration and Coffee 8:15 – 8:30 Welcome and Introductions 8:30 – 9:30 Identification of Occupational and Environmental Health Issues 9:30 – 10:00 Elements of a Comprehensive Pharmaceutical Occupational Health Program and Integration into Drug Development Program 10:00 – 10:15 Break 10:15 – 10:30 Video – Powder Handling 10:30 – 11:00 Group Exercise - Scenario - Part I - Crisis Response 11:00 – 11:45 Occupational Toxicology – Part I 11:45 – 12:15 Industrial Hygiene (IH) Analytical Chemistry 12:15 – 1:15 Lunch 1:15 – 1:45 Group Exercise – Determining Occupational Categorization 1:45 – 2:35 IH Sampling 2:35 – 3:00 Video - "Working Safely with Pharmaceutical Chemicals" and "Modern Pharmaceutical Manufacturing" 3:00 – 3:15 Break 3:15 – 4:10 IH Exposure Controls - Part I (Traditional) 4:10 – 4:30 Group Exercise - Scenario Part II - Crisis Management 4:30 – 4:45 Summary of Day 1 Day 2 Time Topics 8:00 – 8:15 Registration and Coffee 8:15 – 9:00 Occupational Toxicology - Part II (OELs) 9:00 – 9:50 Group Exercise – OEL Setting 9:50 – 10:15 Video - "Safe Handling of Potent Compounds" 10:15 – 10:30 Break 10:30 – 11:30 IH Control Elements - Part II (Advanced) 11:30 – 12:00 Occupational Toxicology - Part III (ASLs and Medical 12:00 – 1:00 Lunch 1:00 – 2:00 Group Exercise - IH Sampling 2:00 – 2:30 Environmental Toxicology 2:30 – 3:00 Risk Communication 3:00 – 3:15 Break 3:15 – 4:00 Group Exercise - Scenario - Part III - Risk Communication 4:00 – 4:20 Process Hazard Review, Program Management and Summary 4:20 – 4:45 Post-test and Evaluation (Boot Camp I) What You'll Learn in The Potent Compound Safety "Boot Camp"® Introduction and Identification of Occupational and Environmental Health Issues Potential of pharmaceutical substances to cause occupational illness Case Studies Regulatory Requirements Overview of Comprehensive Pharmaceutical Occupational Health Program Elements Integration of EH&S Elements Into Drug Development Templates Occupational Toxicology Definition of "potent compounds" Compound Categorization and Handling Practices System (Control Banding) Setting Occupational Exposure Limits (OELs) Setting health-based acceptable surface limits (ASLs) Medical Surveillance Industrial Hygiene Analytical Chemistry Sampling and Analytical Methods Development Setting Analytical Targets Method Validation Surface Sampling Method Validation Sample Submission and Analysis IH Sampling Developing a sampling strategy Techniques for potent compound air monitoring Techniques for potent compound surface monitoring IH Control Elements Factors Leading to Potential Exposures Engineering Controls and Containment Administrative Controls and Procedures Personal Protective Equipment Facility Design Elements Environmental Toxicology Fate and Effects Determination Potential of pharmaceutical substances to cause environmental impairment Cleaning and Waste Disposal Options Regulatory Requirements (in U.S., Canada and abroad) Impact on Drug Approvals Process Hazard Review Techniques Concepts Gathering appropriate information Design development stage Pre start-up and Post Operational Review Program Management and Summary Incident Investigation and Risk Communication Summary Exercises

Update Contact Information

Update Your Contact Information

Thank you for updating your contact information.

Return to Home Page

First NameLast NameTitleCompanyAddressCityStatePostal CodeCountryPhoneFaxEmailCommentsSubject  

Update Your Contact Information

Thank you for updating your contact information.

Return to Home Page

2016 Boston Nov 1-3 Boot Camp

SafeBridge Consultants Announces TWO Potent Compound Safety Courses: The original POTENT COMPOUND SAFETY “BOOT CAMP” and ADVANCED CONCEPTS COURSE: “BOOT CAMP II” November 1-3, 2016 Boston, MA (USA) SafeBridge Consultants, Inc. is pleased to announce two training course offerings: 1. Potent Compound Safety “Boot Camp” (

Potent Compound Safety Triangle

Industrial Hygiene Analytical Chemistry • Sensitive analytical methods as low as picograms/filter • HPLC/RIA/ELISA methodologies • Air and surface limit methods • Method validation • Air and surface sample analysis Toxicology • Acceptable/Permitted Daily Exposures (ADEs/PDEs) • Occupational Exposure Limits (OELs) • Cat

Ganetespib Surface IH Sample Method

Ganetespib ng/sample Surface

Tenofovir DF LQL Air IH Sample Method

Tenofovir DF LQL μg/sample Air

Pergolide Mesylate Surface IH Sample Method

Pergolide Mesylate ng/sample Surface

Enbrel Etanercept Air IH Sample Method

Enbrel, Etanercept Enbrel, Etanercept 185243-69-0 SBM130-R0 HPLC-UV 37 mm teflon filter, 1 μm pore size (Millipore) and support pad in 3-piece polypropylene cassette 3 L/min 110 L 3.1 At ~ -20 °C for at least 7 days On blue ice 2007-05-23 Air

Tenofovir DF LQL Surface IH Sample Method

Tenofovir DF LQL ng/sample Surface

Tenofovir DF Air IH Sample Method

Tenofovir DF ng/sample Air

Pergolide Mesylate Air IH Sample Method

Pergolide Mesylate ng/sample Air

Norethindrone Acetate Surface IH Sample Method

Norethindrone Acetate ng/sample Surface

Naproxen Sodium LQL Air IH Sample Method

Naproxen Sodium LQL ng/sample Air

Naproxen Air IH Sample Method

Naproxen ng/sample Air

Irinotecan HCl Surface IH Sample Method

Irinotecan HCL ng/sample Surface

Ethinyl Estradiol Surface IH Sample Method

Ethinyl Estradiol ng/sample Surface

Enclomiphene Citrate Surface IH Sample Method

Enclomiphene Citrate ng/sample Surface

Enclomiphene Citrate Air IH Sample Method

Enclomiphene Citrate; Trans-Clomiphene Citrate; Androxal Enclomiphene Citrate 7599-79-3 SBM231-R0 HPLC-UV 25 mm Teflon filter, 1.0 micron pore size, cat. FALP02500, support pad, in 3-pc polypropylene cassette 2 L/min 50 L 50 At ambient temperature for at least 8 days At ~ –20 °C for at

Dimethyl Fumarate Surface IH Sample Method

Dimethyl Fumarate, DMF, BG12 Dimethyl Fumarate 624-49-7 SBM194–R0 HPLC-UV SBM193-R0 (air), issued on 8/05/2011 CleanTips swabs, Large Alpha swab, cat TX714A, TWTexwipe Methanol 1.8 Stainless Steel - Recovery 80.2% Bench - Recovery 75.2% Glass - Recovery 78.2% Attention! Correction fa

Butalbital Air IH Sample Method

Butalbital, Florinal Butalbital 77-26-9 SBM059–R0 HPLC-UV 37 mm teflon filter, 1 micron pore size, support pad, in 2-piece polypropylene cassette 3 L/min 200 L 2 At least 8 days at ambient temperature At least 18 days at 2-8 ºC or at ~ -20 ºC Ambient temperature 2003-06-2

Betamethasone Sodium Phosphate Surface IH Sample Method

Betamethasone Sodium Phosphate 151-73-5 SBM255–R0 HPLC-UV CleanTips Swabs: 2 Large Alpha Sampling Swabs TX715, cat. TWTX715, Methanol 1.00 µg/sample Stainless Steel – 67.4% Delrin – 94.4% Teflon – 100% Polyethylene Terethphalate (PET-P) – 95.7% Polyurethane – 104% “Stonehard” flooring ma

Betamethasone Acetate Surface IH Sample Method

Betamethasone Acetate 987-24-6 SBM254–R0 HPLC-UV CleanTips Swabs: 2 Large Alpha Sampling Swabs TX715, cat. TWTX715, Methanol 0.9 µg/sample Stainless Steel – 98.1% Delrin – 97.4% Teflon – 92.6% Polyethylene Terethphalate (PET) – 98.6% Polyurethane – 79.6% “Stonehard” flooring material – 7

Lactase Air IH Sample Method

Lactase ng/sample Air

Armour Thyroid Power T4 Air IH Sample Method

T4, Levothyroxine, Porcine Thyroxin in Armour Thyroid Armour Thyroid Power (T4) NA SBM234-R0 ELISA 25 mm Teflon, 1 micron pore size; support pad; in 2-pc polypropylene cassette 3 L/min 210 L 2.59 At least 21 days at ambient temperature, 2 - 8 °C, and ~ -20 °C Ambient, overnight

Acitretin Air IH Sample Method

Acitretin Acitretin 55079-83-9 SBM-EHS035 –R0 Air HPLC 37 mm teflon filter, 1 micron pore size, support pad, in 2-piece polystyrene cassette 3 L/min 100 L 50 At ambient temperature for at least 42 days, protected from light at 2 - 8 ºC for at least 42 days Ambient temp

Abarelix Surface IH Sample Method

Abarelix, Plenaxis, PPI-149, PPI-149-CMC 183552-38-7 SBM039-A-R0 surface ELISA Two 37 mm glass fiber filters, 1 m pore size; in glass test tube with Teflon lined screw cap 0.1% TFA/DI Water 2.5 ng/sample Stainless steel - 93.1% Aluminum - 86.0% Plastic Caps - 87.4% Rubber Stoppers - 89.5%

Cefdinir Surface IH Sample Method

Cefdinir Cefdinir 91832-40-5 SBM104 –R0 HPLC-UV CleanTips swabs, 2 Large Apha swabs, cat. TX714A, TWTexwipe Methanol/ H2O/Acetic Acid (30%/70%/0.02%) 100 Door – 89.1% Floor – 77.2% Wall – 81.0% Stainless Steel – 46.5% At ~ -20 ºC for at least 22 days Cold on ice pack 20

Milnacipran HCl Air IH Sample Method

Milancipran HCL ng/sample Air

Tamsulosin HCl Air IH Sample Method

Tamsulosin HCl ng/sample Air

Triptorelin Acetate Surface IH Sample Method

Triptorelin Acetate and Lyophilised Tiptoreline ng/sample Surface

Triptorelin Acetate Air IH Sample Method

Triptorelin Acetate ng/sample Air

Ranolazine HCl Air IH Sample Method

Ranolazine HCL ng/sample Air

Naproxen Sodium LQL Surface IH Sample Method

Naproxen Sodium ng/sample Surface

Mannitol Air IH Sample Method

Mannitol ng/sample Air

Lyophilised Triptorelin Surface IH Sample Method

Triptorelin Acetate and Lyophilised Tiptoreline ng/sample Surface

Lansoprazole Air IH Sample Method

Lansoprazole ng/sample Air

Lactose Surface IH Sample Method

Lactose ng/sample Surface

Lactose Air IH Sample Method

Lactose ng/sample Air

Irinotecan HCl M1 Air IH Sample Method

Irinotecan HCL M1 ng/sample Air

Fosamax Air IH Sample Method

Fosamax ng/sample Air

Fluorouracil Surface IH Sample Method

5-Fluorouracil ng/sample Surface

Fluorouracil Air IH Sample Method

5-Fluorouracil ng/sample Air

Fluocinolone Acetonide ELISA Air IH Sample Method

Fluocinolone Acetonide (ELISA method) ng/sample Air

Floxuridine Air IH Sample Method

Floxuridine ng/sample Air

Flomax Air IH Sample Method

Flomax ng/sample Air

Ganciclovir Air IH Sample Method

Ganciclovir ng/sample Air

Doxycycline Hyclate Air IH Sample Method

Doxycycline Hyclate Doxycycline Hyclate 24390-14-5 SBM011-R0 HPLC-UV 37 mm Teflon filter, 1 micron pore size, Support pad, 2-pc polypropoylene cassette 2 L/min 50 L 0.5 μg/cassette At least 2 weeks at room temperature At least 2 weeks at 2 - 8 °C Ambient temperature 1999

Digoxin EIA Air IH Sample Method

Digoxin, Lanoxin, Lanoxicaps, Digitek Digoxin 20830-75-5 SBM089-R0 EIA Two glass fiber filters, 37 mm, 1 micron pore size; in 2-pc polystyrene cassette 3 L/min 100 L 1.5 At least 7 days at ambient temperature or 2 - 8 °C Ambient temperature, overnight 2004-12-10 Air

Cefaclor Surface IH Sample Method

Cephalosporin, Cefaclor Cephalosporin: Cefaclor 53994-73-3 SBM077-P-R0 HPLC-UV CleanTips swabs, 2 Large Alpha swabs, cat. TX714A, TWTexwipe DI water or 100 μg/mL Sodium Carbonate At ~ –20 °C for at least 4 days Cold, dry ice 2004-03-16 Surface

Calcitriol Surface IH Sample Method

Calcitriol; 1α, 25-dihydroxyvitamin D3; 1α, 25-dihydroxycholecalciferol; Rocaltrol 32222-06-3 EHS056P-Addendum 1 RIA Two 37mm Glass fiber filters; in glass test tube with Teflon lined screw cap 95% Ethanol/DI Water 0.3 ng/sample Stainless Steel: 83.2% At least 14 days at 2-8° On ice pac

Butoconazole Nitrate Air IH Sample Method

Butoconazole Nitrate, (Femstat), (Gynazole-1) Butoconazole Nitrate 64872-77-1 SBM-EHS013 HPLC-UV 37 mm Glass Filter, 1 micron pore size; support pad; in 2-pc polystyrenecassette 3 L/min 5 L 0.5 Not Available Ambient temperature overnight 1989-08-11 Air

Alendronate Sodium Air IH Sample Method

Fosamax; Alendronate Sodium; Aronat Alendronate Sodium 121268-17-5 SBP046 HPLC-UV 37 mm glass fiber filter, 1 micron pore size(A/E), support pad, in 2-piece polypropylene cassette 1 L - 4 L/min 15 L 2,500 2.5 μg/sample At ambient temperature for at least 28 days A

Zopiclone Air IH Sample Method

Zopiclone ng/sample Air

Niraparib Tosylate Surface IH Sample Method

Niraparib Tosylate ng/sample Surface

DMx cDMx Surface IH Sample Method

DMX DMX N/A SBM262-R1 ELISA Two CleanTips swabs TX714A; in polypropylene test tube with dual position cap containing 1 mL of stabilizing buffer 10% Ethanol in 0.05 M carbonate/bicarbonate buffer pH 9.6 20 μg/sample At least 7 days at 2 - 8 °C On ice pack, overnight 201

DMx cDMx Air IH Sample Method

Conjugated DMX (c-DMX) c-DMX N/A SBM262-R1 ELISA 25 mm Teflon, 1 micron pore size; support pad; in 3-pc polypropylene cassette 3 L/min 250 L 10 μg/sample At least 7 days at 2 - 8 °C On ice pack, overnight 2015-07-09 Air

Norgestimate Air IH Sample Method

Norgestimate ng/sample Air

Levonorgestrel Air IH Sample Method

Levonorgestrel ng/sample Air

Etretinate Air IH Sample Method

Etretinate, Tegison, Tigason Etretinate 54350-48-0 SBM002-R0 HPLC-UV 37 mm Teflon filter, 0.5 micron pore size, Support pad, 2-pc polystyrene cassette 3 L/min 125 L 0.05 At least 21 days at ~ -4 °C On ice pack, covered from light 1998-05-07 Air

Efavirenz Air IH Sample Method

Efavirenz Efavirenz 154598-52-4 SBM171-R0 HPLC-UV 37 mm Teflon filter, 0.45 micron pore size, Support pad, 2-pc polystyrene cassette 2 L/min 30 L 0.025 μg/cassette At least 7 days at ambient temperature At least 60 days at ~ -20 °C Ambient temperature 2010-03-02 Air

Tobramycin HPLC Air IH Sample Method

Tobramycin Tobramycin 32986-56-4 SBM072–R0 HPLC-UV 37 mm teflon filter, 1 micron pore size, support pad, in 2-piece polypropylene cassette 3 L/min 100 L 2000 2 μg/sample At least 7 days at ambient temperature At least 15 days at ~ -20 °C Protected from light Ambient temperatu

Digoxin HPLC Air IH Sample Method

Digoxin Digoxin 20830-75-5 SBM090–R0 HPLC-UV Two 37 mm glass fiber filters, 1 micron pore size (A/E), in 2-piece polystyrene cassette 3 L/min 500 L 150 At ambient temperature for at least 3 days At 2 - 8 °C or ~ -20 °C for at least 21 days Ambient temperature 2004-12-13

Fluocinolone Acetonide HPLC Air IH Sample Method

Fluocinolone Acetonide (HPLC-UV method) ng/sample Air

Ethinyl Estradiol HPLC Air IH Sample Method

Ethinyl Estradiol (HPLC-UV method) ng/sample Air

Pancrelipase Air IH Sample Method

Pancrelipase Alpha Amylase ng/sample Air

Vesanoid Air IH Sample Method

Tretinoin, Vesanoid Vesanoid 302-79-4 SBM-EHS052–R0 HPLC-UV 37 mm teflon filter, 1 micron pore size, support pad, in 2-piece polystyrene cassette 3 L/min 100 L 50 μg/sample At ~ -20 ºC for at least 14 days, protected from light Cold on ice pack, protected from li

Ranolazine Surface IH Sample Method

Ranolazine Free Base ng/sample Surface

Ranolazine Air IH Sample Method

Ranolazine (Free Base) Ranolazine Free Base 95635-55-5 SBM-EHS031–R0 HPLC-FL 37 mm glass fiber filter, 1 micron pore size (A/E), support pad, in 2-piece polystyrene cassette 3 L/min 100 L 500 0.5 μg/sample At ambient temperature for at least 21 days At ~ -20 °C for at least 21