What are the newest Annex 1 Single use Requirements and does the BioCapt Single use Impactor meet them?
The new EU GMP Annex 1 rev 12 states, regarding single use:
Chapter 8 . Production and Specific Technologies
Paragraph : Single use systems (SUS)
Annex 1 rev Dec 2017 – (8.117): Single use systems (SUS) are those technologies used in manufacture of sterile medicinal products which are designed to replace reusable equipment. SUS are typically defined systems made up of components such as bags, filters, tubing, connectors, storage bottles and sensors.
Annex 1 rev Feb 2020 – (8.121): SUS are those technologies used in manufacture of sterile medicinal products which are used as an alternative to reusable equipment. SUS can be individual components or made up of multiple components such as bags, filters, tubing, connectors, storage bottles and sensors.
Paula Lazzeri, EMEA Field Application Specialist Sterility Assurance/Microbiology, Particle Measuring Systems, points out that there are several considerations when choosing a single use solution, including:
- Adsorption, leachable and extractable (interaction with product contact surface)
- The fragile nature of SUS could be more fragile than fixed/ reusable systems.
- Increase in number and complexity of manual operations and connection made
- Design of assembly
- (Performance of the pre-use integrity test: for filters)
- Integrity testing
- Pin-hole and leakage
- The potential for compromising the system at the point of opening the outer packaging
- Assessment of supplier (including sterilization of SUS)
- Risk of particulate contamination
Paola goes on to discuss the BioCapt Single Use microbial impactor and its relation to these requirements.