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Filtration, separation and purification

Trusted Partner

Trusted Partner

Biotechnology, medical and laboratory

Certified Company

Certified Company

ISO 9001:2015 Certification

Validation of Bio-manufacturing Filters for Pharmaceuticals

In the highly competitive pharmaceutical industry, Alfa Chemistry can provide your employees with the technological advantages they need to succeed. The rich pharmaceutical experience enables our employees to have a practical understanding of the industry and its filtration needs. Our experience translates into unparalleled customer service, enabling customers to obtain the best filtration performance while still meeting economic and compliance standards. Alfa Chemistry can provide you a complete validation package, including written and face-to-face support.

How Can We Help?

Alfa Chemistry's validation experts develop the unique test protocol for each customer, provide complete validation guidelines and documentation packages. Customer support can be carried out in our own laboratory or in the customer's facility.

Our verification services are tailored to each customer's unique fluid and process conditions. They specify the testing, control, and pre-validation tests to be performed to ensure that all test equipment is properly designed and the test methods are scientific and reasonable. Before the work started, all agreements were approved by all parties. We can usually verify and provide a complete report within a month, always faster than our competitors.

Validation of Disposable Filtration System

Leading Validation Services

Alfa Chemistry provides you with various validation services, including but not limited to the following:

  • Microbiology Services

Our testing experts specialize in sterile filtration, mycoplasma removal and virus removal. The fully equipped laboratory uses bioburden-specific organisms or standard challenge organisms to conduct microbiological challenge research on customer products under the worst processing conditions.

  • Compatibility Screening

A rigorous analysis of the potential interaction between the filter assembly and the medicine is carried out to ensure that the filter will not adversely affect the medicine.

  • Product-based Integrity Testing

The integrity test value is determined by testing the actual product; the test value is based on the customer's preferred test method, including bubble point, diffusion or pressure retention, and is carefully established and recorded.

  • Filter Quality Certification Program

All medical filters are accompanied by a quality certificate with published data.

  • Microbial Retention Research

Alfa Chemistry usually conducts filter retention studies on pharmaceutical products under extended processing conditions. This includes protocol development, viability and inhibition testing, and the use of standards to challenge microorganisms or bioburden specific organisms.

  • Extractables Testing

The model solvent was subjected to gravimetric non-volatile residue (NVR) determination; the extract was subjected to additional GC-MS analysis.

Leading Verification Services

  • Additional Documents

Alfa Chemistry can provide information on structural materials, performance data, sterilization protocols, and integrity test values according to customer requirements.

  • Filter Process Reviews

Alfa Chemistry staff can visit customers on site to conduct technical reviews, record and analyze system performance, and help ensure compliance.

Our products and services are for research use only and cannot be used for any clinical purpose.