Extractables & Leachables Understanding and Practice

Jennifer L. Riter
Senior Director, Analytical Services and Integrated Solutions
11 & 13 Nov 2019

©2019 by West Pharmaceutical Services, Inc.

All rights reserved. This material is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any
means, electronic, mechanical, photocopying or otherwise, without written permission of West Pharmaceutical Services, Inc.
 Fit for Purpose

▪ Understanding a holistic view of qualifying packaging

and delivery systems with drug products

Container
Closure Particulate
Integrity
Fit for
Purpose

Extractables
& Leachables Performance
© 2019 West Pharmaceutical Services, Inc. All rights reserved

3
Basic Requirements and
Understanding
Compendia
▪ Regulatory expectation that materials for pharmaceutical
uses comply with local regulations and compendia
▪ Suitability for use is not assured via compendia
compliance
▪ Material composition must be considered
▪ Material/component can pass the compendia tests, but
based on composition may be suited for one application,
but not another.
Desmond Hunt-USP Training Course, 2011

Meeting pharmacopeia specifications does not mean it is qualified for

intended use
Containment Systems Compendia
▪ USP <381> Elastomeric Closures for Injections
▪ USP <660> Containers - Glass
▪ USP <661> Plastic Packaging Systems and Their
Materials of Construction
▪ Ph. Eur. 3.2.9 Rubber Closures for Containers for
Aqueous Parenteral Preparations, for Powders and for
Freeze-Dried Powders
▪ Ph. Eur 3.2.1 Glass Containers for Pharmaceutical Use
▪ JP 7.03 Test for Rubber Closure for Aqueous Infusions
▪ JP 7.01 Test for Glass Containers for Injections
Compendial Standard Updates
Current <381> versus New <382>
Current USP <381> Proposed General Chapter USP <382>
(Elastomeric Closures for Injections) (Elastomeric Component Functional Suitability in
Parenteral Product Packaging/Delivery Systems)
• Functionality Tests
• Package and Delivery System Integrity Tests
oPenetrability
• Needle and Spike Access Functional Suitability
oFragmentation
Tests
oSelf-Sealing
oPenetration Force
Capacity
oFragmentation
oNeedle Self-Sealing Capacity
oSpike Retention and Sealability Capacity
• Plunger Functionality Tests
oPlunger Break Force and Plunger Glide
Forces
oPlunger Seal Integrity
• Tip Cap and Needle Shield Functional
Suitability Tests
Updated USP <382>
Package and Delivery Systems ISO-Informed Testing:
• Vial and Bottle Systems
• Ref ISO 8362-2 and -5, ISO 8536-2 and -6, and ISO 8871-5.
• BFS Systems
• Ref ISO 15759
• Plastic Systems e.g. Film Bags
• Ref ISO 15747
• Cartridge lined seal and plunger
• Ref ISO 11040-2 and -3, ISO 13926-2 and -3, and ISO 11608-3
• Syringe plunger, needle shield and tip cap seal
• Ref ISO 11040-8 and -4
• Single-use syringes
• Ref ISO 7886-1 to -4 and ISO 8537
 Updated USP <382>
Package and Delivery System Integrity Tests:
➢Maximum Allowable Leakage Limit (Ref USP <1207>)
➢Inherent Integrity – leak rate or leak size (Ref USP <1207>)

• 30 samples per test with each sample integrity tested according to leak test
method of choice
• For systems like syringes with a plunger and a needle shield
separate/different types of leak tests may be required
• Chosen leak tests to be capable of verifying systems’ inherent integrity to
MALL for the intended product packaging/delivery system.
USP <1382> and <382> Changes

Source: Daniel Bantz, West Pharmaceutical Services. PDA Container Closure Performance and Integrity Conference, June 2018
Early Package Compatibility/Comparison
▪ Intended to gather information on how
different package candidates may react
with a particular product or matrix (Only
provides gross differences)
▪ Can be performed using
▪ Drug product placebo
▪ Drug product
▪ Other solution to mimic extracting
propensity of the drug product
Early Package Compatibility/Screening
▪ Samples can be stored at temperature in which
product does not degrade (e.g. 50ºC at 0, 4, and 8
weeks)
▪ Product/Package Combination 1
▪ Product/Package Combination 2
▪ Bulk in Teflon™ container used as a control
sample

▪ Methods used: Non-matrix specific and qualitative

▪ HPLC or LC/MS
▪ GC/MS
▪ ICP, ICP/MS, IC
▪ pH of sample solution
▪ Microscopy (if applicable)
Biocompatibility
Biocompatibility Data for Combination Product Components
Standard Tests PFS Example
▪ Cytotoxicity
▪ ISO 10993-5
▪ Sensitization
▪ ISO 10993-10
▪ ASTM Hemolysis
▪ (ASTM F756 and ISO 10993-
4)
▪ Intracutaneous Reactivity
▪ ISO 10993-10
▪ Systemic Toxicity (Acute Systemic
Injection)
▪ (ISO 10993-11)
 Biocompatibility of a System
Testing USP IS0 JP ChP

Cytotoxicity (In vitro MEM Elution) <87> 10993-5 7.03 not required if N/A
USP 87 Grade 0

Cytotoxicity JP N/A N/A 7.03 required if USP 87 N/A

Grade 1 or higher

Systemic Toxicity (In vivo) <88> 10993-11 7.03 required if USP 87 0004200/5-2015
Grade 1 or higher

Intracutaneous Toxicity <88> 10993-10 N/A N/A

Irritation and Skin Sensitization <1184> 10993 -10 N/A N/A

Hemolysis N/A 10993-4 N/A 0003200/3-2015

USP Biocompatibility Anticipated Changes
Extractables and
Leachables
Science versus Compliance – Patient Safety
Extractable = Potential
Migrant

Leachable = migration of extractable

into finished drug
Contact Materials Contribute
Leachables into Drug Products

Regulatory Agencies Demand Proof of Safety-Quality-Efficacy

Sources of Extractables and Leachables
▪ Extractables and leachables can come from any
packaging
▪ Elastomers
▪ Plastic
▪ Glass
▪ Paper
▪ Adhesives and Inks
▪ There are no inert materials, nothing is free of
extractables.
Why are Extractables Important?
▪ Used for selection/qualification for use of materials
▪ Necessary to determine targets enabling the
development of analytical methods for leachable
testing
▪ Useful for quality control for acceptance of container
closure system components

Market focus on patient confidence and safety

Why are Leachables Important?

▪ May interfere with drug product assays.

▪ e.g. Same retention time as drug in HPLC assay
▪ May interfere with medical diagnostic tests.
▪ May cause oxidation, degradation of drug product to an unacceptable
level.
▪ May react with drug product or drug product components.
▪ e.g. May cause precipitate or pH change; Zn/epinephrine in
dental anesthetics
▪ May affect quality and stability of final product.
▪ e.g. modification or aggregation of biologic
▪ e.g. EPREX loss of effect associated with PRCA
▪ May be of toxicological concern
Regulatory Guidances
ICH Q6A
i) Extractables: Control of extractables from
container/closure systems is considered significantly
more important for parenteral products than for oral
liquids. However, where development and stability data
show evidence that extractables are consistently below
the levels that are demonstrated to be acceptable and
safe, elimination of this test can normally be accepted.
This should be reinvestigated if the container/closure
system or formulation changes.
EMA Regulatory Guidances
▪ Note for Guidance on Development Pharmaceutics (1998)
▪ Note for Guidance on Development Pharmaceutics for
Biotechnological and Biological Products, Annex to Note for
Guidance on Development Pharmaceutics (1999)
▪ Note for guidance on stability testing: Stability testing of new drug
substances and products (2003)
▪ Common Technical Document for the registration of
Pharmaceuticals for Human Use; Module 2 + 3 (Nov. 2003)
▪ Guideline on Plastic Imediate Packaging Materials;
(EMEA/CVMP/205/04) effective 1 Dec 2005
USP Informational Chapters <1663> & <1664>

▪ <1663> Packaging/Delivery System Extractables

▪ Informational general chapter presents a framework for the
design, justification, and execution of an extractables
assessment for pharmaceutical packaging and delivery systems

▪ <1664> Assessment of Drug Product Leachables

Associated with Pharmaceutical Packaging/Delivery
Systems
▪ Informational general chapter presents a framework for the
design, justification and implementation of a drug product
leachables assessment for a pharmaceutical
packaging/delivery system
 E&L Definitions USP <1663> and <1664>
▪ Extractables – Organic and Inorganic chemical entities that are
released from a pharmaceutical packaging/delivery system and
into an extraction solvent under laboratory conditions.
Extractables themselves, or substances derived from
extractables have the potential to leach into the drug product
under normal conditions and thus become leachables.

▪ Leachables – Organic and Inorganic chemical entities that are

present in a packaged drug product because they have migrated
into the packaged drug product from a packaging/delivery
system, packaging component or packaging material of
construction under normal conditions of storage and use or
during drug product stability studies.
 USP <1663> Extractables Assessments
▪ Framework for the design and justification for extractables assessment
▪ Not prescriptive but Informs process for extractables:
▪ Scouting
▪ Discovery
▪ Identification
▪ Quantitation
▪ Considers impact of packaging/delivery systems on drug
development i.e.
▪ Effects of manufacturing processes (e.g., sterilization) on
potential leachables
▪ Worst-case potential leachables profile in a manner which
facilitates leachables studies
▪ Establishment of qualitative and quantitative leachables–
extractables correlations
▪ Assessment of patient exposure to chemical entities
USP <1663> Utilization of Extractables Assessments
▪ Extractables assessments can:
▪ Characterize Packaging/delivery systems components
materials of construction
▪ Facilitate the selection of components and materials
▪ Understand the effects of processes like sterilization
▪ Establish worst-case potential leachable profile to
facilitate evaluation of probable leachables
▪ Facilitate leachable-extractable correlations
▪ Facilitate investigations to the origin of identified
leachables
 Extraction Studies
▪ Material Characterization (Ingredients as Probable Extractables and
Potential Leachables) – Starting Point
• Screening of material candidates (e.g., components)
• Establish material composition (ingredients) and general
biocompatibility
• Rigorous, broad based extraction and testing methods
• Semi-quantitative assessment for toxicological alerts
• Outcome: materials either approved for further consideration or
rejected
▪ Controlled Extraction Study
• The overall laboratory processes required in order to create
extractables profile(s) of particular pharmaceutical
packaging/delivery systems, packaging components, or
materials of construction
• Multiple solvents, preparation and analytical techniques
Extraction Study Considerations
An initial, qualitative/semi-quantitative determination of the
types of chemical species that can be extracted from a
material under extreme conditions that are designed to be
more rigorous than anything the material would
experience under actual use.
▪ Focused on individual components of the system
▪ Use of multiple solvents of various polarities and
solvent properties
▪ Use of known and surrogate standards to obtain semi-
quantitative data
▪ Identification and estimation of target compounds
Extractable Study Considerations
▪ Solvents
▪ Water (pH 2, 7,
Techniques Purpose
10)
▪ IPA LC/MS

▪ IPA/Water GC/MS direct injection Organic Extractables

▪ Hexane GC/MS Headspace

▪ Others ICP Elemental profile

▪ Preparation IC Ionic species

▪ Soaking
▪ Sonication
▪ Reflux/Soxhlet
▪ Microwave
▪ Sealed Vessel
 Analytical Evaluation Threshold
▪ The AET is the threshold at/above which an extractable
and/or leachable should be reported.
▪ Derived directly from SCT
▪ SCT for OINDP = 0.15 µg/day
▪ SCT for PODP = 1.5 µg/day
▪ Considers Doses per day; Doses per container
▪ Incorporates Mass of component

The AET does not indicate whether or not the

extractable or leachable is safe, only whether it
should be reported.
 Example AET calculation
AET= (SCT*Dt)/( Dd*m)

▪ SCT = Safety Concern Threshold = 1.5 μg/day

▪ Dt = Total Labelled Doses = 2
▪ Dd = Doses per Container = 1
▪ m = Mass/weight of Component = 0.45 g

AET = 6.67
 USP <1664> Leachable Assessment
▪ Framework for the design and justification of drug product
leachables
▪ Intended for drug product developers, manufacturers,
and suppliers for understanding sources of leachables
▪ How to evaluate and manage leachables during the
drug development/manufacturing process
▪ Does not establish specific
▪ analytical methods
▪ specifications/acceptance criteria for any drug
product or packaging system!
USP <1664> Utilization of Leachable Assessments
▪ Facilitate the timely development of safe and
effective drug products
▪ Identify trends in drug product shelf life studies of
leachable accumulation
▪ Facilitate change-control processes for drug
packaging/delivery systems
▪ Facilitate investigations into the origin of identified
leachables whose presence causes OOS results
for marked drug
Leachable Studies
▪ Specific to Drug Product
▪ Target/sensitive method development
▪ Robust methods to discover unexpected
▪ Method optimization and validation

▪ Established by Full Shelf-Life Stability Studies

▪ Accelerated testing not always indicative
▪ A system found acceptable for one drug product is not
automatically assumed to be appropriate for another
Leachables Studies
▪ Detection of a leachable
▪ Safety assessments for the level found will
be applied to the drug product
▪ What is an acceptable level for one drug
product may not be for another due to
therapeutic use and administration of the
drug
 Leachables Assessment

▪ Methods should be validated

▪ An un-validated method is not valuable in the eyes of
a regulatory agency
▪ Detection levels should be meaningful
▪ Too high and data will not be pertinent to patient
safety
▪ Too low and analytical detection will be challenging
▪ Multiple lots of drug product should be evaluated
▪ Accounts for variability
USP <1664> Leachable Assessment
▪ Framework for the design and justification of
drug product leachables
▪ Intended for drug product developers,
manufacturers, and suppliers for
understanding sources of leachables
▪ How to evaluate and manage leachables
during the drug development/manufacturing
process
▪ Does not establish specific
▪ analytical methods
▪ specifications/acceptance criteria for
any drug product or packaging
system!
USP <1664> Utilization of Leachable Assessments
▪ Facilitate the timely development of safe and
effective drug products
▪ Identify trends in drug product shelf life studies
of leachable accumulation
▪ Facilitate change-control processes for drug
packaging/delivery systems
▪ Facilitate investigations into the origin of
identified leachables whose presence causes
OOS results for marked drug
Addressing the Regulatory and Quality
Requirements in Extractables and
Leachables
Extractables and Leachables Proven Approach

▪ Material Characterization
▪ Individual component assessment
▪ Controlled Extractables Study
▪ Risk Assessment
▪ Simulation Study
▪ Probable leachable study
▪ Data Assessment
▪ Determine targets for leachables
▪ Leachables Study
▪ Method Development and
Validation
E&L Approach

Pre-Planning and Component Selection:

Evaluate available vendor information and
literature searches to select appropriate
materials

Assessment and Evaluation:

Assess the Extractable information and design “fit
for purpose” studies

Risk Assessment:
Evaluate and organize extractable data based on
risk ranking

Leachables Evaluation:
Develop and validate Leachables Methods and
monitor over the shelf life of the drug product
Component Selection
▪ What information am I able to obtain from
my vendor as to material characteristics and
safety?
▪ Extractable information
▪ Regulatory certificates of additives of
concern
▪ Does this material have inherent properties
to be hazardous?
▪ Formulation characteristics
▪ Extractable information
▪ Regulatory certificates of additives of
concern
▪ Decision point: Select components
 Pre-Planning and Component Selection
▪ Is the container closure system “Fit for Purpose” for
the pharmaceutical in question? What vendor data is
available?
▪ Formulation Characteristics/Material Data
Sheets, Theoretical Extractables Lists and other
vendor information
▪ Material Characterization – analytical studies
designed to cast a wide net

THE WORK DOES NOT STOP HERE – FIRST STEP IN

THE JOURNEY
E&L Approach

Pre-Planning and Component Selection:

Evaluate available vendor information and
literature searches to select appropriate
materials

Assessment and Evaluation:

Assess the Extractable information and design “fit
for purpose” studies

Risk Assessment:
Evaluate and organize extractable data based on
risk ranking

Leachables Evaluation:
Develop and validate Leachables Methods and
monitor over the shelf life of the drug product
Extractable Assessment and Evaluation
▪ What information is available to evaluate
patient risk? What is missing?
▪ Have all compounds (volatiles, semi-volatiles,
inorganic, non-volatiles) been evaluated?
▪ Has testing been completed in a solvent similar
to the drug product?
▪ What is the drug product contact (time and
temperature) and how can that increase or
decrease patient risk?
▪ What is missing based on what the vendor
provided?
▪ Decision point: What additional
evaluations, if any, are needed?
Extraction Study Considerations
▪ Consider all systems that come in
contact with the product during its life
cycle:
▪ Raw material containers
▪ Processing equipment
▪ Intermediate containers
▪ Packaging equipment
▪ Final container closure
▪ Delivery devices
Extraction Study Considerations
▪ Some vendors provide potential extractable
(PE) lists for their materials
▪ These theoretical lists, based on information
about the raw materials and manufacturing
process, can be helpful in the determination of
feasible targets or for identification of
unknowns detected during the extraction study
▪ They should not be used in place of
extractables data because potential of
migration is not used as a factor of what goes
on the list
Extraction Study Considerations
An initial, qualitative/semi-quantitative determination of
the types of chemical species that can be extracted
from a material under extreme conditions that are
designed to be more rigorous than anything the
material would experience under actual use.
▪ Focused on individual components of the system
▪ Use of multiple solvents of various polarities and
solvent properties
▪ Use of known and surrogate standards to obtain
semi-quantitative data
▪ Identification and estimation of target compounds

Post Processing / Sterilizing

Extractable Study/Material Characterization Considerations
▪ Solvents Techniques Purpose
▪ Water (pH 2, 7, 10) LC/MS
▪ IPA GC/MS direct injection Organic Extractables
▪ IPA/Water
▪ Hexane GC/MS Headspace
ICP Elemental profile
▪ Others IC Ionic species
▪ Preparation
▪ Soaking
▪ Sonication
▪ Reflux/Soxhlet
▪ Microwave
▪ Sealed Vessel
Analytical Evaluation Threshold - How Low?
▪ The AET is the threshold at/above which an
extractable and/or leachable should be reported.
▪ Derived directly from SCT
▪ SCT for OINDP = 0.15 µg/day
▪ SCT for PODP = 1.5 µg/day
▪ Considers Doses per day; Doses per
container
▪ Incorporates Mass of component
The AET does not indicate whether or not the
extractable or leachable is safe, only whether
it should be reported.
Orally Inhaled and Nasal Drug Products 2006; pqri.org
 Example AET calculation
AET= (SCT*Dt)/( Dd*m)

▪ SCT = Safety Concern Threshold = 1.5 μg/day

▪ Dt = Total Labelled Doses = 2
▪ Dd = Doses per Container = 1
▪ m = Mass/weight of Component = 0.45 g

AET = 6.67
Identification Categories
▪ Confirmed:
▪ Mass spectrometric fragmentation behavior
▪ Confirmation of molecular weight or confirmation of
elemental composition
▪ Mass spectrum matches automated library or mass
spectrum and chromatographic retention index match
authentic specimen
▪ Confident:
▪ Sufficient data to preclude all but the most closely related
structures have been obtained
▪ Tentative:
▪ Data have been obtained that are consistent with a class
of molecule only
▪ Unknown: Insufficient data exist to categorize
Additional Considerations
for Extractables

55
Changes in Extractables Profile can
Result from Lifecycle Management
Cumulative Component
Experience Storage Potential
Sterilize Changes to
Coat
Wash Extractables
Film Profile

Bulk Device
Vial Syringe

Drug Product Lifecycle

Management
Sterilization Assessment - Extractables

Impact to Specific Drug Application

E&L Approach

Pre-Planning and Component Selection:

Evaluate available vendor information and
literature searches to select appropriate
materials

Assessment and Evaluation:

Assess the Extractable information and design “fit
for purpose” studies

Risk Assessment:
Evaluate and organize extractable data based on
risk ranking

Leachables Evaluation:
Develop and validate Leachables Methods and
monitor over the shelf life of the drug product
Risk Assessment
▪ What is the relative risk of the compounds found?
▪ Tools:
▪ E2L (West tool)
▪ Toxicological Assessments
▪ Consultation/Industry references
▪ Not all drug products carry the same amount of risk
▪ Indication
▪ Patient population
▪ Route of administration
▪ Decision point: Which analytes, at what levels, should move to
leachable development, validation and monitoring?
Assessment of the Extractable Data

Extractables Risk Assessment

•Evaluate the extractables highlighting
analytes of concern
•Special Case Compounds Present
•Solubility
• Potential Toxicity
•Assessment completed for specific drug of
interest and container closure system
•Dosing regime
•Product shelf life
Simulation Study
▪ Designed with the DP of interest and packaging system in mind
▪ “Realistic worst-case conditions” to have the same propensity to
extract as the drug formulation (drug placebo or other simulant)
▪ Simulate properly = probable leachables
▪ Spike and recovery on extractables of interest prior to
simulation to be sure you can detect/quantitate to a low enough
level for meaningful results
▪ Establish extractables as worst case leachables
▪ Accelerated conditions designed to mimic worst case exposure
▪ Use of justified simulating solvents and extraction conditions
▪ Safety risk assessment of all extractables above the AET
▪ Used to delineate target leachables
▪ Outcome: Extractables that are deemed to have an acceptable
safety risk are not considered further; target leachables are to
be accessed via leachable study
E&L Approach

Pre-Planning and Component Selection:

Evaluate available vendor information and
literature searches to select appropriate
materials

Assessment and Evaluation:

Assess the Extractable information and design “fit
for purpose” studies

Risk Assessment:
Evaluate and organize extractable data based on
risk ranking

Leachables Evaluation:
Develop and validate Leachables Methods and
monitor over the shelf life of the drug product
Complex Drug Product Matrix - Leachables
Leachable Studies
Specific to Drug Product
▪ Target/sensitive method development
▪ Robust methods to discover unexpected
▪ Method optimization and validation
Established by Full Shelf-Life Stability Studies
▪ Accelerated testing not always indicative
▪ A system found acceptable for one drug product is not
automatically assumed to be appropriate for another
FDA Guidance for Industry:
Container Closure Systems for Packaging Human Drugs and Biologics
Leachables Stability Data

Accelerated

3 Month
Real Time
Leachables Studies
Detection of a leachable

▪ Safety assessments for the level found will be

applied to the drug product
▪ What is an acceptable level for one drug product
may not be for another due to therapeutic use and
administration of the drug
Leachables Assessment
▪ Methods should be validated
▪ An un-validated method is not valuable in the
eyes of a regulatory agency
▪ Detection levels should be meaningful
▪ Too high and data will not be pertinent to patient
safety
▪ Too low and analytical detection will be
challenging
▪ Multiple lots of drug product should be
evaluated
▪ Accounts for variability
A Leachable is Detected – Next Step
▪ There is no inert packaging
▪ Consult with a toxicologist
▪ Anything can be toxic in high enough
doses
▪ They will assess the chemical, quantity
found, and dosing regimen of the drug
E&L Approach
Vendor Info:
Material Pre-Planning and Component Selection:
Characterization
Evaluate available vendor information and
Reports, PEL’s,
literature searches to select appropriate
FC’s/MDS
materials

Extractables study Gap Assessment and Evaluation:

specific to DP, Assess gaps in the Extractable information
migration studies and design “fit for purpose” studies

Risk Assessment:
What to focus on for
Leachables? Evaluate and organize all extractable data
based on risk ranking

Leachables Evaluation:
Method Dev, Develop and validate Leachables
Validation, Methods and monitor over the shelf life
Leachables Testing of the drug product
© 2019 West Pharmaceutical Services, Inc. All rights reserved
Making Informed Decisions

▪ Begin with engaging your suppliers

▪ Supplier information should be a starting

point

▪ Industry must understand supplier challenges

and suppliers must understand
customer/industry needs

Knowledge transfer throughout the

process is critical to achieving success
71
Conclusion
▪ It is important to have an understanding and a holistic
view of qualifying packaging and delivery systems with
drug products for extractables and leachables
▪ Begin qualifying the packaging and delivery system
early in development
▪ Extractables and leachables, is key to properly
qualifying the package and delivery system
 West Analytical Lab Services

Innovation Partnership Knowledge Value

Our goal is to establish West as a

Scientific Destination
 ▪ cGMP and developmental lab
services
ANALYTICAL
▪ Robust data generation
LABORATORY informs knowledge and
SERVICES conclusions

▪ Enable and collaborate to

From Early build scientific strength and
Development new capabilities
Through ▪ Provide analytical support
Market expected by the industry
leader in containment and
Support delivery systems
Our Proven Global Analytical Capabilities

✓350+ method development and

validations
✓65+ global lab service customers
✓Average 15 years industry experience for
lab personnel
✓Over 100 approved drug products
successfully tested by West Analytical
Services
✓Successful regulatory body audit history
✓Participant in RX360 Audit program
 Analytical Laboratory Expert Services

Extractables Container Performance Particle

/Leachables Closure
Integrity
▪ Expertise in USP Chapters ▪ Expertise in USP Chapter
<1663>, <1664> and ICH <1207>
Q3D
▪ Helium Leak Detection
▪ Migration of label
▪ Low temperature
adhesive/inks
capability temperature
▪ Risk assessment analysis
▪ Leachables ▪ High Voltage Leak
▪ Toxicological assessments Detection
▪ ▪ Laser Absorption
Methods development and
validation Analysis (O2)
▪ Vacuum Decay
& Analysis
Functionality
▪ Design verification ▪ USP <788>, <789>
studies on combination and <790>
products
▪ Packaging
▪ ISO 11040, 22413, 11608 components expertise
and 8536-2 for Analysis
• Elastomers,
▪ Assistance with polymers, metals
identification of Essential
▪ Secondary packaging
Performance
materials
Requirements.
▪ Customized performance
testing
 Expertise
Extractables Packaging &
and areas CCI
& Leachables Performance
Particle Analysis

of focus
Knowledge Material
West AnalyticalScience Regulations
Lab Services
Packaging & Delivery
Systems/Combination Products

ISO DEA Class I-V License

Facility cGMP 9001:2008
15378:2001
RW0270102
FDA Registered
3002804236
EMA
Certification
 Experience
Expertise in analytical services for containment/delivery
systems and combination products in pharmaceuticals
and biotechnology

▪ 85+ Scientists
▪ Avg. 15 years experience
▪ Capabilities
▪ Study design
▪ Performance testing
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Dedicated Project Management Office
▪ Analytical Services’ Project Management Office (PMO)
collaborates with all key stakeholders to provide
technical expertise and solutions to exceed customers’
expectations and meet agency requirements
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for managing our customers’ projects

Propose Define Execute Review Reporting/Close

Questions?
 Contact Information
Name: Ms. Jennifer Riter
West Pharmaceutical Services
530 Herman O. West Drive
Exton, PA 19341 USA
E-mail: Jennifer.Riter@westpharma.com
Phone: +01 610-594-3137

© 2019 West Pharmaceutical Services, Exton, PA. All rights reserved. This material is
protected by copyright. No part of it may be reproduced, stored in a retrieval system,
or transmitted in any form or by any means, electronic, mechanical, photocopying or
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