Alfa Chemistry provides filter validation services for our clients to comply with regulatory requirements. Alfa Chemistry has many years of research experience in the biopharmaceutical industry. We have an in-depth understanding of the regulatory environment, and we adopt a tailor-made consulting approach to each client. This makes us the perfect partner to solve your verification-related challenges, even after your project is completed.
Learn About Our Validation Services
We can assist you in monitoring the safety of your filter goods. Whether you are implementing disposable systems or traditional devices, Alfa Chemistry can provide you with the necessary verification services. Our services include extensive testing of all process components: bags, container sealing systems, mixing systems, sterile filters, transfer systems, membrane adsorbers, virus filters, etc.
Extractables and Leachables Testing
Validation is essential to ensure filter product quality and patient safety. Thanks to our unique expertise in the extractables and leachables esting field, we know exactly which compounds can be found in our products. We can provide extractables evaluation, extractables research, extractables and leachables esting storage research, extractables test, and safety assessment. Our risk-based approach can help medical product manufacturers determine the best process for scaling up from the laboratory to commercial production.
Sterile Filter Validation
Alfa Chemistry can help you complete sterile filter verification. Our verification experts support you in determining the verification requirements and appropriate test ranges for all filters. We can provide microbiological research, physical and chemical research, and transportation and storage verification. Our verification service ensures a reliable production process that meets legal requirements.
Virus Clearance Validation
Virus safety is one of the top concerns of biopharmaceuticals and pharmaceutical manufacturers. Alfa Chemistry's virus removal service completes all virus removal steps in a short turnaround time, up to six weeks. We can provide you with the feasibility study, process design and optimization, as well as the experimental design of the filter.
Validation of Disposable Filtration System
As an integrator of single-use systems, Alfa Chemistry can provide reliable verification assistance for users of single-use systems. We have product knowledge and laboratory analysis expertise, and can complete system verification projects of various sizes and structural materials at one time.
Validation for Pharmaceutical and Biomanufacturing
Alfa Chemistry helps our customers shorten the time to market of new and existing products in the highly competitive pharmaceutical business by providing solutions that meet the verification criteria of filtration disposable systems. Our expertise translates into unrivaled customer service, allowing customers to get the finest filtration performance while staying under budget and meeting regulatory requirements.
The experts of Alfa Chemistry have rich experience in a series of verification services and are good at applying advanced technology to provide accurate and reliable results to meet all the requirements in the industry. To learn more about our verification services or talk to one of our experts, please contact us immediately.
