Packaging & Cleanroom Technology
Clean Processes — From Primary Packaging to the Full Line
Packaging processes place high demands on the production environment: particles and micro-organisms in the room air can contaminate products, jeopardise regulatory approvals and trigger recalls — whether pharmaceuticals, medical devices, cosmetics or high-value industrial goods.
PETEK delivers clean packaging environments across a wide range of industries — from simple clean zones with HEPA filtration through mini-environments for individual packaging machines to fully qualified cleanrooms of class ISO 5. All solutions are designed and documented to ISO 14644.
Our Focus Areas
Primary Packaging, Sterile Packaging & Industrial Lines
Primary Packaging for Pharma & Medical Devices
Pharmaceuticals, implants and sterile medical devices must be packaged under low-particle conditions of class ISO 5 to ISO 8. PETEK delivers these areas with HEPA H14 filtration, positive-pressure airlocks and complete qualification documentation to EU GMP Annex 1.
Sterile Packaging & Sterile Blisters
Sterile packaging to ISO 11607 — pouches, trays, blisters — must be manufactured and tested under cleanroom conditions to preserve the sterile barrier up to the point of use. PETEK designs the appropriate cleanroom class and documents the entire packaging process for regulatory audits.
Cosmetics & High-Value Consumer Goods
Cosmetics, personal care products and high-value consumer goods benefit from particle- and germ-controlled packaging environments. PETEK delivers clean zones of class ISO 7 to ISO 9 that integrate seamlessly into existing production lines.
Mini-Environments for Packaging Machines
A full cleanroom is not always necessary: a mini-environment above the packaging station protects the product precisely at the critical point — with laminar flow hood, HEPA filtration and positive pressure. PETEK supplies these solutions as a turnkey unit, adapted to existing machines and line concepts.
Standards Expertise
Standards & Requirements in Packaging Technology
PETEK knows the relevant standards and certification requirements of the packaging industry. Our cleanrooms are planned and documented so that they satisfy the requirements of auditors and authorities — from a simple clean zone to a GMP-qualified packaging line.
- ISO 14644-1 & -2 — cleanroom classification and particle monitoring
- ISO 11607 — sterile packaging for medical devices
- GMP / EU GMP Annex 1 — good manufacturing practice for pharma packaging
- EU GMP Annex 15 — qualification and validation
- HEPA H14 / ULPA — particle and microbial reduction in supply air
- ISO 14698 — biocontamination control in cleanrooms
Typical Applications:
- → Primary packaging for pharmaceuticals & medical devices
- → Sterile and blister packaging to ISO 11607
- → Packaging of cosmetics & personal care products
- → Mini-environments above packaging machines
- → Industrial packaging lines (ISO 7–9)
- → Aseptic filling & packaging
PETEK Services
From Clean Zone to Qualified Packaging Line
Cleanrooms ISO 5 to ISO 9 to ISO 14644
For all packaging requirement classes
HEPA H14 and ULPA filtration
Particle and microbial reduction in supply air
Mini-environments & laminar flow hoods
Directly above the packaging station
Hygienic personnel & material airlocks
Controlled transitions to GMP standards
Qualification documentation for audits
EU GMP, ISO 11607, Annex 1 & 15
Turnkey solution from a single source
Planning, construction, commissioning, service
Clean Packaging Environment for Your Facility?
Our sales engineers know the requirements of the packaging industry. Get in touch — no obligation.