- Details
-
By Elisabet Martí
The manufacturing of sterile pharmaceutical products is subject to some of the strictest regulations in the industry: Annex 1 of the EU Good Manufacturing Practices (GMP). This guideline sets out the requirements to ensure microbiological quality and safety for products administered via parenteral, ophthalmic, otic, or other sensitive routes.
A challenge for sterile dosage forms
Although Annex 1 is often associated with injectables, it also directly applies to products like ophthalmic and otic drops, which require a sterile environment to avoid contamination. Manufacturers of these pharmaceutical formats must ensure that all machinery components in contact with the product can be sterilized.
Even though the bottles in an unscrambler or feeder are empty, the criticality of each project may require that Annex 1 compliance extends to the unscrambler as well.
How does POSIMAT help?
At POSIMAT, we have a deep understanding of the technical and regulatory requirements of Annex 1 GMP. That’s why we have designed unscramblers that can be disassembled and sterilized in an autoclave. This ensures that all parts in contact with empty bottles are sterilized, fully complying with Annex 1 GMP guidelines.
Furthermore, our equipment is engineered for seamless integration into laminar flow environments, preserving sterility throughout the feeding process.
This ensures that:
- Automatic feeding of bottles and jars can take place in controlled environments.
- Human intervention is reduced, minimizing contamination risks from accumulation tables.
- Line throughput and production efficiency are significantly improved.
Common cases: Ophthalmic and otic drops
Manufacturers of eye and ear drops typically use plastic bottles that must be unscrambled quickly and precisely, without compromising their sterility. POSIMAT offers high-speed solutions that ensure smooth, hygienic bottle handling fully aligned with sterile production requirements.
Compliance, efficiency, and safety
Investing in equipment that complies with Annex 1 is not just a legal obligation—it’s a guarantee of patient safety and brand reputation. POSIMAT collaborates closely with pharmaceutical manufacturers and line integrators to deliver tailored engineering solutions for sterile production.