GMP Cleanrooms to EU GMP Annex 1
GMP Grade C to D — the right class for every process step
Pharmaceutical manufacturing processes are classified according to GMP Grades A to D — depending on the contamination risk of each process step. PETEK realises GMP Grades C and D: from non-sterile dosage form manufacturing in Grade C to packaging and support areas in Grade D.
The revised EU GMP Annex 1 (2023) places increased requirements on contamination control, monitoring and qualification. PETEK knows these requirements and plans cleanrooms that will withstand today's and future audits.
Our Focus Areas
GMP Cleanrooms for every process step
Non-Sterile Dosage Form Manufacturing (Grade C)
Tablet manufacturing, granulation processes and soft gel production often fall under GMP Grade C. PETEK plans these areas with the required airlock concepts, pressure cascades and HVAC systems for defined cleanroom classes.
Pharmaceutical Packaging (Grade C/D)
Primary packaging (vials, ampoules, blister packs) and secondary packaging are processed in Grade C or Grade D areas. PETEK delivers the appropriate cleanroom solutions including material airlocks and transfer systems.
Qualification & Validation Support
GMP cleanrooms must be qualified (IQ/OQ/PQ) and regularly re-qualified. PETEK accompanies the entire lifecycle — from planning and construction through to ongoing re-qualification and regulatory inspection.
Standards Expertise
GMP Grades & Regulations at a Glance
PETEK realises GMP cleanrooms of Grade C and D as well as ISO classes 7 and 8 — for non-sterile dosage form manufacturing, pharmaceutical packaging and support areas.
- GMP Grade C (ISO 7) — Non-sterile dosage form manufacturing
- GMP Grade D (ISO 8) — Packaging & support areas
- EU GMP Annex 1 (2023) — latest revision
- FDA 21 CFR Part 211 — for US-approved products
- IQ/OQ/PQ qualification documentation complete
Typical Applications:
- → Aseptic filling & lyophilisation
- → Vaccine production & biopharmaceuticals
- → Tablet manufacturing & granulation
- → Primary packaging (vials, ampoules, syringes)
- → Quality control laboratories
- → Biotechnology production environments
GMP cleanroom for your pharmaceutical facility?
Our sales engineers are familiar with the regulatory requirements of the pharmaceutical industry. Contact us — free of charge and without obligation.