Sterilizing Process Validation Switching to Parker sterilizing grade filters
Validation of Parker filters within a sterilization process can be carried out to meet both regulatory and customer requirements. Our technical services team will work with you to understand, optimize and validate your sterile filtration process 8 simple steps to process improvement
We work with you to establish the most effective filtration solution for your process based on your goals and desired process improvements including: • Minimizing product loss • Reducing downtime • Increased yields • Reduce over processing • Guarantee sterility • Minimizing risk to your process • Extending service time • Promoting best practice Once the correct Parker filters have been chosen, we work closely with you to qualify the use of our products within your process. Development of an application specific strategy Our Technical Support team use your identified parameters to determine the qualification package required. This demonstrates that our filters are capable of meeting the performance goals required of your process. We follow the specific requirements of the current revision of ISO134081 and guidance from PDA Technical Report No. 262 to validate the sterile filtration step in your process. Test work is carried out by our experienced team of Scientists and Engineers in our dedicated test facilities. Meeting the standards Global investment programmes have created first class R&D, manufacturing and support facilities across the world. We are committed to industry standards including current versions of: • ISO 9001 - Quality Management Systems • ISO 13485 - Quality Management Standards for medical devices • ISO 14001 - Environmental Management 1 ISO13408-2 Aseptic Processing of Healthcare Products - Part 2: Sterilizing Filtration 2 PDA Technical Report No. 26: Sterilizing Filtration of Liquids Remove the barriers to successful validation Supported by state-of-the-art technical facilities and a specialized international team of dedicated Engineers and Scientists, Parker is committed to supporting your validation process. parker.com/bioscience
01 Making the right choice Match products to performance criteria When selecting the appropriate filter system or membrane it is important to consider the following to ensure optimal performance: • Bacterial retention/ retention efficiency • Required flow rate • System size • Ability to be sterilized • Disposable manufacturing • Cleaning / reuse requirements • Physiochemical interactions of the filter in the product - Adsorption - Compatibility - Potential leachables / extractables safety • Batch volume • Product loss • Operational ranges • Regulatory compliance Small scale process simulation Testing can be carried out on-site or in our dedicated laboratory where small scale process simulation can be carried out directly on your product by our dedicated team of scientists. Filter selection and sizing To meet your current and future expectations, we work with you to define your process requirements and select the appropriate membrane materials and system size.
02 Developing a validation strategy Developing an agreed strategy Consultation is carried out between our process specialists and your quality and production teams to assess the worst case conditions in your process. This is carried out through a series of discussions and questionnaires which define your validation requirements. In a customer approved protocol we will agree the filter validation strategy including; • Dedicated contact • Time-scales • Volumes of product required • Worst-case conditions • Simulation scale • Scope and extent of testing Our experience within this field allows us to develop protocols based on previous qualification work with similar products. We can then reduce and simplify the qualification process for your application while identifying and removing potential problems before they arise. Made to match your process We tailor protocols to ensure appropriate validation is conducted for your process. parker.com/bioscience
03 Challenge organism viability assessment Challenge organism selection criteria Historically, Brevundimonas diminuta has been used to rate sterilizing grade filters at a concentration in excess of 107 organisms per cm2 of effective filter area (EFA) with testing carried out following current revision of ASTM F838 test methodology. It is important to determine if the standard challenge organism is viable in the process fluid for the exposure time required, simulating the expected period of filter use. As per ISO13485, where organisms are non-viable, alternative organisms or surrogate process fluids may be recommended. In bactericidal fluids, active ingredients may be removed to simulate process conditions or an inert carrier can be substituted. Testing is carried out by our Laboratory Support Group in our dedicated bio-containment facility. We inoculate your product and assess challenge organism viability over a designated time period. Naturally occurring bioburden can also be isolated and identified at this stage. Determining the organism for your bacterial challenge Verify whether the standard challenge organism is viable and if not determine an alternative organism or surrogate process fluid.
04 Determination of product wet integrity test parameters Developing test parameters We can correlate the integrity test parameters to your product. This testing will enable you to minimize the number of steps in your production process including: • Water wetting of the filter • Solvent flushing • Drying / water removal or purging • Validation of the above stages on active ingredients Establishing the ratio between water wet testing and product wet testing determines new values for integrity test pressure, diffusional flow and bubble point. Enabling PUPSIT and post use integrity testing in product Providing test parameters will give you Pass / Fail criteria unique to your product minimizing the amount of disruption and product loss, providing greater control and accuracy. parker.com/bioscience
05 Filter conditioning and compatibility Stressing the filter Parker uses simulation test rigs and analytical equipment to provide an accurate simulation of your process under laboratory conditions. Tests include; • Long term contact studies • Cyclical steam testing • CIP chemical cleaning simulation • Extreme temperature exposures • Flow rate performance • Lifetime • Dimensional and gravimetric measurements • Microscopy • Porometry • Integrity testing • Visual inspection • Post contact viability assessment Simulating your process Creating a true and accurate assessment of our filters to give you complete confidence in performance.
p 06 Bacterial retention strategy Challenging the filter Bacterial retention studies give us accurate analysis of how a diminutive organism will respond in a given fluid. The fluid characteristics have a direct impact on cell size and therefore, the filter’s retention capability. Typical change factors may include: • Osmolarity • pH levels • Growth factors • Antimicrobial effects • Temperature • Ionic strength The filter retention may also be influenced by it’s interaction with the process and therefore, the filters tested in the process compatibility stage are used for the bacterial challenge. When carrying out a bacterial challenge test to rate our 0.2 micron sterilizing grade filters, Parker follow guidelines laid out in the current revision of ASTM F838. Providing sterility assurance Tailored bacterial challenge testing, recognizing that each process in unique. parker.com/bioscience
07 Extractables and leachables analysis Ensuring product safety Parker meets strict industry guidelines for ensuring toxicity, animal derived materials and bio-compatibility of our products An extractable is a chemical removed from the material by an artificial or exaggerated force for example solvent, temperature or time. Parker can provide extractables studies for representative filters, following the draft of USP <665>. An independent toxicology study can be made to determine risk in your product. A leachable migrates from the contact surface into the process fluid during normal use. Parker can organize leachables testing in your product, following the draft of USP <665> or BPOG methodology. Impurities It is a regulatory expectation that filter users investigate, minimize and remove (where possible) the level of extractables (soluble material) within the manufacturing process.
p 08 Final reporting strategy Validation reporting All aspects of your validation process are fully documented with a view to ensuring clear compliance during an audit. The digitally supplied validation pack includes: • Validation protocols signed-off by all stake holders. • Validation reports signed-off by all stakeholders. • All test records. • All relevant equipment telemetry Further information is digitally stored and available on request: • Calibration certificates for equipment used. • Reagent and solution preparation records. • Quality certificates for all reagents used. • Equipment telemetry • Bacteria culture records. Documented evidence Demonstrating that best practice recommendations and guidelines for sound filter qualification have been followed. parker.com/bioscience
EMEA Product Information Centre Free phone: 00 800 27 27 5374 (from AT, BE, CH, CZ, DE, DK, EE, ES, FI, FR, IE, IL, IS, IT, LU, MT, NL, NO, PL, PT, RU, SE, SK, UK, ZA) US Product Information Centre Toll-free number: 1-800-27 27 537 © 2023 Parker Hannifin Corporation. All rights reserved. Catalogue BRO_BEFE_Sterilizing Process Validation Rev: 01 parker.com/bioscience
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