Frequently Asked Questions (FAQ)
Q-1: Does EU GMP Annex 1 require the use of isolators?
A: Not necessarily. Annex 1 recognizes both isolators and Restricted Access Barrier Systems (RABS), provided they effectively control contamination risks and are supported by a documented Contamination Control Strategy (CCS).
Q-2: What materials are recommended for sterile filling machine product-contact parts?
A: Product-contact components are typically manufactured from 316L stainless steel, with FDA-compliant elastomers and tubing. Electropolished surfaces and hygienic fittings are recommended to facilitate cleaning and sterilization.
Q-3: Can a sterile filling machine comply with both EU GMP Annex 1 and FDA requirements?
A: Yes. Many modern aseptic filling systems are designed to meet EU GMP Annex 1, FDA cGMP, and 21 CFR Part 11 requirements, making them suitable for global pharmaceutical manufacturers.
Q-4: Which pharmaceutical products require Annex 1-compliant filling equipment?
A: Annex 1-compliant sterile filling machines are commonly used for eye drops, injectable drugs, nasal sprays, inhalation anesthetics, sterile oral liquids, vaccines, biologics, and other aseptically manufactured pharmaceutical products.
