sterility assurance Prove the power and your processes

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Ezra Logan
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1 sterility assurance Prove the power and efficacy of your processes

sterility assurance programs: an introduction YOUR CHALLENGES Contamination events cost a lot of time and money. Sterility problems can lead to product recalls.

2 sterility assurance programs: an introduction YOUR CHALLENGES Contamination events cost a lot of time and money. Sterility problems can lead to product recalls. Inadequate process validations are being cited by FDA. Validation guidelines are vague. Inferior processes can cause back orders. OUR SOLUTION Comprehensive services are tailored to suit your needs and linked to provide a complete picture for regulatory agencies. Expertly designed validation programs. Support for ongoing environmental monitoring. Total testing program management. Dedication to superior execution. assurance Why work with WuXi AppTec? Regulatory expectations for medical products have changed, requiring more testing and more data. WuXi AppTec has the expertise that can help the process be easier, faster, and more successful. EXPERIENCED WuXi AppTec s scientists have over 20 years experience with hundreds of validations and diverse devices. ENGAGED Our industry-recognized experts serve on the standards committees that write reusable device guidances. RECOGNIZED As an industry leader, we have partnered with most of the major medical device companies. INTEGRATED We offer seamless services in all of the disciplines required to complete reusable device studies. 2

3 our program components WuXi AppTec offers total program components for sterility assurance, including: Clean Room Design Requirements Develop the specifications to meet your environmental needs. Clean Room and Utility Systems Validation and Monitoring Prove the cleanliness of your environment and the quality of your utility systems. Cleaning Validations Prove the efficacy of your cleaning process. Reprocessing Validations Prove the efficacy of your cleaning, disinfecting & sterilization methods. Sterilization Validations Prove the strength of your sterilization methods. Dose Audits / Lot Release Prove the stability of your process over time. Packaging Validation Prove the integrity of your packaging. our proven process CONSULT TO DETERMINE NEEDS DESIGN PRODUCT-SPECIFIC PROGRAM EXECUTE CUSTOMIZED TESTING PLAN DELIVER RESULTS Clarify program goals Understand product specifications Consider current regulatory expectations Link study designs Coordinate product transfers Perform sampling plans Provide submissionready testing manual Supply long-term control plan Run customized assays

4 considerations for clean room design Designing clean rooms and utility systems is about more than blueprints and build specifications. You need to use a systematic approach for developing and managing the architecture to optimize the efficiency of your manufacturing processes, ensure the safety of your product, and make it easy to maintain monitoring programs over the long run. Our experts can help you consider all of these important design requirements, based on your product specifications. KEY FACTORS Process flow Materials flow Key microbial control points Water system and process gas control clean room validations using our established process CONSULT ESTABLISH CONTROL STRATEGY EXECUTE STRATEGY & PERFORM VALIDATIONS MAINTAIN CONTROL On-site visit Determine project needs Assess manufacturing/ controlled environments Identify other key areas to monitor Design validation plan Develop: Continuous monitoring program Sampling schedules Sampling procedures Conduct sampling on-site Perform testing Train internal staff Evaluate validation data Recommend limits Suggest monitoring frequency

testing services for controlled environments WuXi AppTec provides manufacturers with testing services designed to help validate, monitor, and ensure the integrity of GMP/controlled environments from

5 testing services for controlled environments WuXi AppTec provides manufacturers with testing services designed to help validate, monitor, and ensure the integrity of GMP/controlled environments from laboratory counters to cleanrooms to entire manufacturing facilities. With our many years of microbiological testing for medical product industries, plus our experience in operating our own in-house manufacturing facilities, we have the expertise to advise you in designing a custom testing program to fit your particular needs. Environmental Monitoring An environmental monitoring program can be used to assess the microbial levels of critical areas and evaluate the effectiveness of various manufacturing controls, including cleaning procedures, HEPA filtration, disinfection, gowning, and aseptic handling procedures. Monitoring of products used during manufacturing, such as water, cleaning solutions and gases, can also be helpful in demonstrating and maintaining environmental control. WuXi AppTec s experts can help you design and implement such a program. A variety of service options are offered: Testing Services You follow your own protocol/test plan for selection of sites and collection of the samples, which are shipped to us for incubation, enumeration, and characterization/identification. We provide you with test results for your analysis. Comprehensive Services We consult with you to develop an appropriate protocol and sampling plan. You follow the established sampling plan, then ship the samples to us for incubation, enumeration, and characterization/identification. We analyze the data and provide a formalized final report that includes the test results and recommendations for establishing Alert and Action levels. Supplemental Services On-site assessment & monitoring ID of environmental isolates Tracking of isolates Trending of results Training of your personnel for sample collection Rental of air sampler Culture media for sampling purposes Disinfection Process Efficacy This type of study is used to evaluate the log reduction of a disinfection process used on products or materials. It evaluates specific disinfection agents, alone or in combination, and is usually conducted with a variety of microorganisms and viruses a panel of organisms typically used for efficacy testing; those of the most concern to product integrity or application; or environmental/product isolates. Efficacy of Sanitizers / Surface Cleaning Validation This type of study is used to determine the efficacy of sanitizing agents on various inanimate surfaces (such as counters, floors, and other areas/materials that are routinely cleaned). It is typically conducted with a variety of microorganisms and viruses most often those that are of concern in the environment or product application. NOTE: Standard methods (ASTM, AOAC, USP, ISO, etc.) can be modified, expanded or otherwise customized for specialized challenges or to fulfill particular requirements. ADDITIONAL SERVICES Microbial Identification Viral Clearance / Inactivation Studies Water Testing / TOC Chemical / Analytical Testing Custom Protocols Consultation Services

cleaning validations Planning a comprehensive strategy for the lifecycle of your sterile product, including cleaning validations, is crucial to avoiding regulatory issues.

6 cleaning validations Planning a comprehensive strategy for the lifecycle of your sterile product, including cleaning validations, is crucial to avoiding regulatory issues. Because cleaning and sanitization processes may have direct impact on product purity, stability, potency, safety and efficacy, global regulatory agencies are requiring a thorough risk assessment and validation of all of your cleaning processes for everything from clean rooms to production equipment to cleaning agents. KEY CONSIDERATIONS Cleaning agents Techniques Time points Surface materials Potential microbial/viral contaminants guidance REGULATIONS The FDA has provided positions on sterilization programs in various guidance documents and warning letters. 21 CFR , Equipment Cleaning and Maintenance, states equipment and utensils shall be cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. The following FDA Guidance Documents are suggested resources for additional information: Guidance for Reprocessing (Draft) Amendments to Sterility Test Requirements for Biological Products WUXI APPTEC EXPERIENCE WuXi AppTec is the clear leader in this field with more than 20 years experience and has developed standard cleaning procedures for bacterial and viral contamination. Our experienced PhD-level virologists and microbiologists have the investigational expertise to identify novel contaminants and develop customized assays for you. For example, simulating the exact spraying and cleaning processes at small scale is critical to ensure that larger-scale cleaning procedures will provide the same results as the validation program.

reprocessing validations Programs designed specifically for your reusable products will result in compelling data answering regulatory demands while supporting patient safety.

APPROVAL Increase your odds of regulatory approval with strong reprocessing data for your device.

IDENTIFY CRITERIA SOIL & INOCULATE CONDUCT TESTING PROVIDE RESULTS Identify the targeted acceptance criteria and develop the best testing protocol to prove the efficacy of your process.

7 reprocessing validations Programs designed specifically for your reusable products will result in compelling data answering regulatory demands while supporting patient safety. PEACE OF MIND Be confident that your reprocessing protocols are effective and your reusable devices will be safe for patients. APPROVAL Increase your odds of regulatory approval with strong reprocessing data for your device. DIFFERENTIATION Stand out from your competition with validated procedures for cleaning, disinfecting, and sterilizing your product. IDENTIFY CRITERIA SOIL & INOCULATE CONDUCT TESTING PROVIDE RESULTS Identify the targeted acceptance criteria and develop the best testing protocol to prove the efficacy of your process. Simulate clinical use by soiling/inoculating device before submission to cleaning, disinfection and sterilization processes. Perform manual and/or automated process(es) and test for quantitative endpoints such as TOC, protein and hemoglobin. Provide a final report, including summary of data and a clear interpretation of proof of process efficacy. WuXi AppTec is able to perform completely in-house the full spectrum of cleaning/disinfecting/sterilizing processes whether manual, ultrasonic or automated allowing faster turnaround times and better sample control. Included in our on-site equipment is a STERIS Used with permission of STERIS Reliance Genfore Washer/Disinfector that offers a wide variety of options to meet specific needs.

microbiology services Microbial assays involve a variety of tests from determination of the numbers and types of organisms naturally present in a product to the assessment of controlled environments.

8 microbiology services Microbial assays involve a variety of tests from determination of the numbers and types of organisms naturally present in a product to the assessment of controlled environments. With our comprehensive menu of microbiology services, WuXi AppTec provides testing across the product development life cycle and beyond: R&D and screening, in-process release and validations, and finished product delivery. Endotoxin Testing Kinetic chromogenic Kinetic turbidimetric Gel clot Determining the reduction of endotoxin contamination is key to proving your production processes are under control and your products are suitable for lot release. Bioburden Testing Aerobic counts Anaerobic counts Fungi/mold counts Spore counts Recovery efficiency validation Selective tests to isolate organisms of interest The type of bioburden testing that should be performed depends on the information that is needed. Controlled Environment Testing Growth and enumeration of air, surface and water samples Growth and enumeration of water coliforms Sampling materials and equipment for testing your critical environments Our scientists can help you manage your entire microbial environmental sampling program. Growth Promotion USP <61> method USP <71> method Additional organisms available to fit your needs. Prepared media must be tested for its ability to support microbial growth prior to use for testing. Microbial Identification ABI 3130 Genetic Analyzer BioMerieux VITEK 2 system DuPont RiboPrinter system WuXi AppTec performs microbial identification and characterization in-house using a number of techniques. Sterility Testing Biological indicators Suitability testing (B/F) Total immersion Membrane filtration Rinse method Product sterility testing is typically performed either as a routine lot release test to monitor product after sterilization or as part of validation programs. Our sterility menu includes methods that comply with ANSI/AAMI/ISO, and USP for solid materials, tissues, fluid path devices, and liquids.

package system testing WuXi AppTec s ISTA-certified laboratory provides manufacturers with an array of services for their packaging systems.

Sterile Barrier System (SBS) Testing WuXi AppTec offers a program of SBS services that features integrity evaluations, seal and whole package strength evaluations, and stability testing with

Available tests include: SBS Seal and Whole Package Strength Testing ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials ASTM F1140 Standard Test Methods for Internal

9 package system testing WuXi AppTec s ISTA-certified laboratory provides manufacturers with an array of services for their packaging systems. Testing services, which can be used to demonstrate compliance with regulatory requirements, include Sterile Barrier System (SBS) and packaging system design qualification testing. Sterile Barrier System (SBS) Testing WuXi AppTec offers a program of SBS services that features integrity evaluations, seal and whole package strength evaluations, and stability testing with accelerated and real-time aging studies. Available tests include: SBS Seal and Whole Package Strength Testing ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials ASTM F1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications SBS Integrity Testing ASTM F1886 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection ASTM F F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration ASTM F 2096 Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test) SBS Stability Testing ASTM F1980 Standard Guide for Accelerated Aging of Sterile Medical Device Packages Real-Time Aging Sample Storage and follow up Packaging System Design Qualification Testing Available tests include: ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems ASTM D7386 Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems ASTM D4332 Environmental Conditioning ISTA 1 and 2 Series ISTA 3A ISTA 4AB ISTA 7D and 7E ISTA Environmental Conditioning

supporting services: chemistry testing From incoming material screening to lot release testing, WuXi AppTec offers a wide range of chemical assays for assessing the safety of medical device materials

Wet Chemistry Analytical Chemistry Physical Properties Gluteraldehyde Residues Conductivity Karl Fischer Moisture Osmolality USP 381 Physicochemical Protein Assay TOC Hemoglobin Carbohydrate USP

10 supporting services: chemistry testing From incoming material screening to lot release testing, WuXi AppTec offers a wide range of chemical assays for assessing the safety of medical device materials and manufacturing processing aids. Wet Chemistry Analytical Chemistry Physical Properties Gluteraldehyde Residues Conductivity Karl Fischer Moisture Osmolality USP 381 Physicochemical Protein Assay TOC Hemoglobin Carbohydrate USP Assays USP Identification Tests USP Heavy Metals EO Residual Panels EO Exhaustive Analysis EO Residuals ECH, EG Residuals Vendor Comparisons Viscosity Specific Gravity Melting Point Boiling Point Flash Point Residue on Ignition Moisture FT-IR Scans Refractive Index UV-VIS Spectrophotometry Turbidity State-of-the-art equipment Highly experienced staff Fully customizable PROGRAM FEATURES testing programs Data integration into risk assessments Qualified methods available R&D, GLP and GMP services Easy access to staff toxicologists Regulatory and consulting services

consulting services Recently, FDA auditors have shown heightened awareness and increased expectations of sterility assurance programs, focusing especially on: Use of ISO 11607 Physical Testing of

from materials selection to cleaning instructions by identifying the current guidance applicable for your product and assisting in the development and implementation of a strategic approach.

11 consulting services Recently, FDA auditors have shown heightened awareness and increased expectations of sterility assurance programs, focusing especially on: Use of ISO Physical Testing of Packaging Sanitizer Efficacy Validations Environmental Monitoring Reprocessing Validations expertise WuXi AppTec scientists and regulatory experts are available to help you address your challenges from materials selection to cleaning instructions by identifying the current guidance applicable for your product and assisting in the development and implementation of a strategic approach. We also specialize in finding the root cause if you ve had a failure, and determining the most effective steps you can take to eliminate the issue. Our experts partner with your team to identify the best paths to avoid costly regulatory failures and move forward for success.

sterility assurance PROGRAM FEATURES Full range of services, with testing to meet regulations worldwide. Expert guidance in designing product-specific testing plans for successful submissions.

12 sterility assurance PROGRAM FEATURES Full range of services, with testing to meet regulations worldwide. Expert guidance in designing product-specific testing plans for successful submissions. Specialized studies in sterilization and reprocessing validations. Total validation program management option. PROVEN EXPERTISE Over 20 years of experience. Expert members on international guidance committees. Leaders/participants on industry committees. Registrations/Certifications: ISO FDA ISTA Products: Biologics Devices Tissues Combination Products Pharmaceuticals Submission-ready validation report manuals. ST. PAUL 2540 Executive Drive St. Paul, MN ATLANTA 1265 Kennestone Circle Marietta, GA PHILADELPHIA 4751 League Island Blvd. Philadelphia, PA PS

STERILIZATION VALIDATION IN THIS SECTION REPROCESSING VALIDATIONS FOR REUSABLE MEDICAL DEVICES. Radiation Sterilization Validation

STERILIZATION VALIDATION IN THIS SECTION REPROCESSING VALIDATIONS FOR REUSABLE MEDICAL DEVICES. Radiation Sterilization Validation STERILIZATION VALIDATION All sterilization processes require validation of the efficacy and reproducibility of the process. Depending on the type of sterilization, this may be accomplished by partial,