Validation Services for Pharmaceutical and Biomanufacturing
In the highly competitive pharmaceutical industry, MTS (Meissner Technical Services) can provide your staff with the technical edge it needs to succeed.
Daily experience with pharmaceuticals has provided the MTS staff with a practical understanding of the industry and its filtration needs. Our experience translates to unsurpassed customer service, allowing clients to attain their optimum filtration performance, while still meeting economic and compliance standards. MTS can provide a complete validation package ready for FDA or other agency’s review, which includes both written and in-person support.
MTS Validation Specialists develop the most effective testing protocols for each unique customer, provide complete validation guides and documentation packages, and even conduct staff training. Customer support may take place within our own laboratories, or at the customer’s facility.
Our test and validation protocols are designed according to latest industry standards and are tailored to the unique needs of each customer’s fluid and set of process conditions. They detail the tests to be performed, the controls and pre-validation tests performed to ensure that all test equipment is properly designed and test methodologies are scientifically sound. Any scaling calculations used for the testing are also detailed so that it is shown clearly how the test work relates to the user’s process. All protocols are approved by all parties before work is started.
Meissner’s MTS Validation group provides complete reports, recommendations, and documentation with the shortest turnaround time of any filtration manufacturer. MTS can generally validate and provide complete reporting in one month, consistently faster than our competitors.
Leading MTS Validation Services
MTS microbiologists are experts in sterile filtration, mycoplasma removal, and virus removal. Fully equipped MTS laboratories perform microbial-challenge studies on customer products, under worst-case processing conditions, using bioburden-specific organisms or standard challenge organisms.
A critical analysis of potential interactions between filter components and the pharmaceutical product is performed to ensure that the filter experiences no adverse effects in the pharmaceutical product.
Product-based Integrity Testing
Integrity test values are established from testing conducted with actual product; test values are based on the customer’s preferred test methodology, including bubble point, diffusion, or pressure hold and are carefully established and documented.
Filter Quality Certification Program
All pharmaceutical filters are shipped with certificates of quality with release data. This helps customers meet FDA or other agency documentation requirements, facilitates incoming materials handling, and minimizes the need for testing by customers.
Microbial Retention Studies
MTS generally performs filter retention studies on pharmaceutical product, under extended processing conditions. This includes protocol development, viability and inhibition testing, and the challenge using either standard challenge microorganisms or bioburden-specific organisms.
A gravimetric non-volatile residue (NVR) determination is made for the model solvent; additional GC-MS analysis is performed on the extract.
Additional GMP Documentation
Upon request, MTS can supply information on materials of construction, challenge protocols, performance data, sterilization protocols, and integrity test values using the customer’s preferred method.
Filtration Process Reviews
MTS staff can visit customers on-site to perform technical reviews, document and analyze system performance, and help ensure regulatory compliance.