Pharmaceutical production isolators
First and foremost is the protection of product, operator and environment
Production isolators for aseptic filling processM+P isolators in double wall design serve as an enclosure for aseptic processes (filling, loading and unloading of freeze dryers). Product protection is achieved by a barrier (manipulation unit and plenum) which separates the operator and the product. HEPA filtered unidirectional air flow provides Grade A conditions preventing particle swirl. Products and materials are transferred into and out of an isolator via transfer systems.
All safety and GMP relevant functions are permanently monitored and archived electronically. Before the filling process commences, the isolator is decontaminated with our patented DECOjet® decontamination system.
Various possibilities are available for the air treatment: independent of process air supply from the clean room/into the clean room, preconditioned air handling from the technical floor or external air conditioning -
M+P covers all these variants.
Production isolators for aseptic/aseptic toxic filling processM+P isolators in single wall design serve as an enclosure for aseptic/toxic filling processes (filling, loading and unloading of freeze dryers). Personnel and product protection is achieved by installing a barrier (manipulation unit and plenum) between the operator and the product. The return air ducts are cleaned automatically (CIP). The work area is cleaned automati-cally or manually (WIP).
HEPA filtered unidirectional air flow provides Grade A conditions preven-ting particle swirl. Products and materials are transferred into and or out of an isolator via transfer systems.
All safety and GMP relevant functions are permanently monitored and archived electronically.
Before the filling process begins, the isolator is decontaminated using our patented DECOjet® system.
- Process according to FDA and cGMP regulations
- A stable, effective and reproducible decontamination process
- Execution of Low Level H2O2 concentration analysis
- Reduzierung der Belüftungs- und Zykluszeit
- Durch den Einsatz von DecoJet® wird eine verbesserte H2O2 Verteilung erreicht
H2O2 flow simulations to identify worst case positions
Integrated H2O2 Decontamination System DECOjet®
- Each DECOjet® system comprises of the vaporizing unit and the H2O2 supply unit with ductwork, tubing and controls
- The DECOjet® utilizes compressed air as the carrier air of the vaporized H2O2, benefit: reproducibility
- Short dehumidification phase of the isolators
- No residues inside the system
- Redundant sensor technology
- Integrated leak test before each cycle
- Low maintenance
- Excellent accessibility for inspection by tri-clamp connection
Homogeneous H2O2 distribution by way of DECOjet® placed near the “worst-case” positions
Patented H2O2 Decontamination System DECOjet®