Process Validation & Equipment Qualification Services
Critical equipment to be considered
Single-use Components or Assemblies
The drivers for the adoption of single-use in a wide array of unit operations are numerous but there are also a few hurdles which need to be overcome to ensure a successful implementation. Among these, Leachables and Extractables concern is cited as the first factor that may restrict the use of disposables in biopharmaceutical manufacturing. Generally speaking, the questioning around the risks that the introduction of such component(s), assemblies or systems pauses is often perceived as a speed hump which can be removed by a proper risk management strategy.
Validation and Qualification needs:
- Demonstrate that the product-contacting equipment does not alter a specific drug product
"Production equipment shall not present any hazard to the products. The parts of the production equipment that come into contact with the product must not be reactive, additive or absorptive to such an extent that it will affect the quality of the product and thus present any hazard."
European Commission, EUDRALEX Volume 4, "Good Manufacturing Practices, Medicinal Products for Human and Veterinary Use", Chapter 3, "Premise and Equipment", 2003
- Demonstrate that under specific conditions, the high performance of the single-use component(s) will not be affected.
Examples of services we provide:
- Design consultancy
- Validation Master Plan & Validation Master File
- Extractables and Leachables - Risk assessment, studies and flushing
- Sub-visible particle shedding evaluation studies
- Chemical compatibility studies
- Product binding studies
- Sterilization validation
- Transportation, Storage and Handling Qualifications
Document Links:
- Extractables and Leachables Validation Services
- Validation and Qualification of Disposable Assemblies in Bioproduction Processes
- Mobius® Validation Services
- Extractables and Leachables for Filters, Bags and Other Components
- Implementation services for Mobius® FlexReady Solution with Smart Flexware® assemblies for chromatography and TFF
- Consulting services for the implementation of single-use systems
- Mobius® FlexReady Solution qualification protocol and services
- Mobius® Disposable Mixing System qualification protocol and services
Webinar:
- Risk Based Assessment of Extractable and Leachable Substances from Single-Use Systems
Presented by: Ross Acucena Regulatory Consultant, Merck
