Regulatory Services - Open Source Filter Validation and Method Development Services

Regulatory Services

At BiOZEEN Regulatory Services (BRS), we offer validation services for filters from all the major filter manufacturers, i.e. a unique service line offering Open Source Validation under one roof, allowing Pharmaceutical customers to choose from a range, where preference meets functionality. We aim at designing the most effective filtration train, in a true sense what is called an “Optimized Filtration Train,” hence enabling you to achieve successful batches and bring molecules Fast &  First to the market.

The suite of Pharmaceutical Services offered include Filter Validation & Method Development Services, which are in compliance with the necessities of international bodies such as US FDA, EU GMP, EMEA, to name a few, also encompassing requirements listed in PDA TR # 26 (rev. Sep 2008).

Filter Validation Services

Being the last unit operation of the drug manufacturing process, sterile filtration plays a critical role in patient safety; thereby, it is a universal regulatory mandate that the sterile filtration step is validated in a process and product-specific manner.

Sterile filtration of pharmaceutical products is the subject of many regulations, guidelines, and standards, which are specific and well developed.

The filter validation services offered by BiOZEEN include:

  • Filtration Train Optimization Study: to assess the series of filter devices including pre-filtration and sterile filtration combination, with an objective to ensure an optimized filtration train capable of providing maximum throughput of the final sterile product without interference between batches.
  • Compatibility Study: plays a pivotal role in submissions pertaining to a new product market authorization and in formulation experiments relevant to changes in the product. It is essential to thoroughly assess the chemical compatibility of the product contact components with all equipment, filter devices, and materials used in the pharmaceutical manufacturing process, in order to avoid delays in the product development process and deviations that could compromise the quality of the end product. Filter integrity is evaluated post-exposure to process fluid at process conditions, as well as predetermined worst-case conditions that include; simulated filter sterilization conditions (for devices), process fluid contact time, and process temperature – to determine that the pore size remains unaffected. This is an essential preliminary indication to reinforce the choice of the membranes to be used in the filtration train.
  • Product-based Integrity Study: The integrity of the filter is its Quality attribute. Sterilizing grade filters require to be tested to assure their integrity pre – and post-filtration process. Integrity values for the test filter are obtained by subjecting it to real-life situations – cleaning & sterilization-in-place, followed by integrity testing under normal manufacturing conditions before establishing product wet integrity values. BiOZEEN specialists also perform drug product based integrity testing on filters to establish product integrity ratio values & product bubble point ratio also.
  • Bacterial Retention Study: Validation of a sterilizing filtration process is critical since it is impossible with currently available technology to measure the sterility of each filled container; therefore, sterility assurance of the filtered product must be achieved through validation of the filtration process, hence proving that sterile filtrate is generated. As a part of this study, the filter is challenged with Brevundimonas diminuta (ATCC 19146) under process conditions and demonstrated by testing to produce a sterile filtrate. The size of B.diminuta is critical for determining the retention characteristics of membrane filters.  At BiOZEEN the bacterial retention study is performed by trained microbiologists who keep the size of the challenge organism to the minimum and as a mono-dispersed suspension.  This creates the worst-case challenge condition to establish the retention capabilities of an SGF which can be correlated to the product base integrity values.
  • Extractable & Leachable Study: The primary function of filter devices is to remove unwanted contaminants from pharmaceutical products.  An ideal filtration device is non-interactive; it does not absorb any active ingredients from the drug, nor impart extractable into the drug product. At BiOZEEN we test the filtration device for its retention characteristics, non-interactive ability, and safety under minimum and maximum operating conditions.
  • Protein/ Preservative Binding Study: Adsorption is a mechanism, which causes the product to bind to the filter membrane; ideally, a filter membrane should not adsorb formula components. Adsorptive filter materials include membrane, hardware & support materials. Adsorption tests are performed at a small scale & confirmed at a large scale to ensure product composition & concentration are not affected by such phenomenon taking into consideration factors such as flow rate, product concentration, contact time, preservative concentration, temperature & pH that can affect the level of adsorption.

Method Development Study

Microbiological Test Method Development is a time-consuming process.

We at BiOZEEN are committed to delivering customized services, ensuring compliance with regulatory needs. Our team of experts would support you in understanding the Microbiology Method Development necessities & Regulatory Requirement (USP/EP) associated with the testing of Finished Products, IPQC Samples & Raw materials. The services include method development for performing:

  • Bioburden Testing
  • Sterility Testing

To obtain more information, you could connect with us at