Integrity Testing Support

Filter Integrity Testing and Associated EquipmentFIL IT Logo

The pharmaceutical industry is very aware of integrity testing IT requirements, with Pharmacopoeial defined Good Manufacturing Practice cGMP leading to a requirement for pre– and post– batch production validation of sterilising grade filter integrity.

Integrity testing is also applied in the Beverage and Medical filtration sectors, but not required by regulation.

To achieve this practically, in-situ testing with automated equipment is the optimum solution, with many integrity test instruments now available to facilitate the process. However, the introduction of the ISPE´s Good Automated Manufacturing Process GAMP 4 guidelines together with the 21CFR11 regulatory requirements for Electronic Records and Electronic Signatures introduced further requirements in development methodology and performance validation for this equipment.

Filter Integrity consultants have many years of experience in this field, including;

  • Responsibility for the design and validation of several integrity test systems and instruments currently in use across the pharmaceutical industry.
  • Serving on Parenteral Drug Association PDA and UK Parenteral Society committees producing current technical guidance for Sterile Filtration applications.
  • Documenting and performing IQ, OQ methodologies and procedures on-site.

We can support both pressure decay, mass flow and aerosol challenge methods and equipment.

Contact us to review your requirements.

Compressed Air Quality Validation

ISO 8573-1 defines quality classes by the level of contamination present in a compressed air line.

Unfortunately there are very few instruments sensitive enough to allow the verification of the quality to the levels identified in the standard, particularly for oil contamination levels.

The development of test instrumentation to allow cost effective quality verification and in situ treatment equipment performance validation is an active area for Filter Integrity and its partners.

Compressed Air Filter Performance Validation

The ISO 12500 series of international standards defines the methods to be used to verify and report performance of compressed air treatment products.

Filter Integrity is developing a capability to independently validate products and is interested to talk to potential partners.

Contact us to review.