A company for the design and manufacture of cleanroom equipment

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1 A company for the design and manufacture of cleanroom equipment Pharmaceutical production Isol ators for aseptic / aseptic-toxic filling

2 Pharmac eutical Production Isolators for Operator, Envi ronment an d Product protection Metall+Plastic sets milestones in the field of isolator technology and process know-how. In the foreground: protection of the product, operator and environment. Unique, patented technologies fulfill customer requirements and excellent service differentiates METALL+PLASTIC in the market. Your requirements You need a partner whose knowledge and technical expertise meets your filling process requirements for stability and reproducibility. Our solutions provide product and user protection, along with fast and reproducible decontamination processes. Our isolators are designed and manufactured to be cgmpcompliant enabling a fast and safe transfer of materials into and out of the containment area. Our solution Aseptic - non toxic Product protection aseptic - toxic Product & operator protection Double wall design Single wall design Grade A production environment Surrounding room class Grade C / D Unidirectional air flow system provides a homogenous air velocity of 0.45m/s +/- 20% at the working position Monitoring of temperature, pressure, air velocity and humidity of the process environment H2O2 decontamination and system integrity testing Isolator leak rate < 5% * Isolator leak rate < 3% * Manual wipe down Manual wash down + automated CIP of return air duct * Depending on requirements

3 Aseptic production isolator with integrated MTC (Material Transfer Chamber), as well as capping section under orabs Self-clamping, inflatable seal, integrated in the door design FDA approved sealing material Fast and easy tool free replacement of door seals

4 Solutions for you r aseptic fi lli ng process Dou ble wall Isolator M+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 or 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, pre-conditioned air handling from the technical floor or external air conditioning - M+P covers all these variants. Double wall / Design for air recirculation Pneumatically sealed doors in safety glass The inflatable seal is installed in the door and not in the frame of the manipulation unit Safety glass is used for the inner pane, serving as the air return duct The inner pane is easy to open (tool-less) for cleaning purpose Easily removable return flow grids between the double pane prevent debris from packaging materials from being sucked into the air return duct The integrity of the inflatable seals is permanently monitored by a pressure switch. Alarms are automatically triggered if the minimum pressure setpoint is crossed Continuous reduction of outgassing H2O2 during production is effected by the patented arrangement of the catalytic converters on top of the filter unit inside the plenum Exhaust air Supply Air HVAC (Heating, Ventilation and Air conditioning) Technical area Supply / Return ducts Interstitial space Cleanroom ceiling Manipulation unit Air recirculation Filling Machine, Lyo Loading / Unloading Grade C / D cleanroom

5 Turnkey line covering all interfaces for an aseptic production isolator Continuous double return wall design Easy cleaning of the inner panes Pneumatic sealed doors made of safety glass and removable return flow grids

6 Solutions for you r aseptic fi lli ng process si ngle wall Isolator M+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 automatically or manually (WIP). HEPA filtered unidirectional air flow provides Grade A conditions preventing 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. External air ducts for air return Safe change of decontaminated filters through BiBo (bag in/bag out) boxes in the technical area Long lifetime through large filter areas Excellent machine accessibility through placement of BiBo boxes in the technical area The replacement of the contaminated filters does not take place in the cleanroom Controlled WFI drainage flow Working CIP sprayballs integrated in the exhaust air ducts Supply air HVAC (Heating, Ventilation and Air conditioning) BiBo-Filter Technical area Supply / Return ducts Filter Fan Unit Interstitial space Grade C / D cleanroom CIP spray balls Manipulation unit Sloped machine base plate Filling machine, Lyo Loading / Unloading

7 Turnkey line covering all interfaces for an aseptic - toxic production isolator Integrated balance grids for return air Machine base plate sloped to drain to ensure complete draining of waste water from wash down WFI expiry External arranged return air ducts

8 Solutions for i n divi dual ai r han dli ng concepts Different facility layouts, as well as differing customer requirements require flexibility and customization of air handling concepts. Together with our customers, we plan and advise the most suitable application. The pressure within the isolator is controlled by the air handling unit. Depending on the process requirement, individual isolator segments can have their own pressure and air-conditioning concept. Filters ensure the necessary cleanliness of the incoming and outgoing air. Maintenance doors with noise insulation Fast and ergonomic filter inspection / replacement (tool-less) Patented catalytic converter arrangement for a reliable and fast aeration Continuous reduction of outgassing H2O2 during production Ai r han dli ng con ept for outsi de ai r Advantages OF outside air handling supply Independent air handling system The room ventilation is self-sufficient and separate of the air handling unit of the building Covers the air volume requirement independently No load on the existing system

9 Air handling concept pre-conditioned air process air from the technical area Advantages of pre-conditioned air handling supply Ideal for new buildings Space saving versus external air handling Can be integrated in existing air handling system Use of existing air handling infrastructure Ai r han dli ng conc ept pr e-con dition ed ai r process ai r from th e c lean room an d r etu r n to th e c lean room Advantages from the cleanroom back into the cleanroom Space saving versus external air handling Air volume balance of the room remains neutral Return of the process air into the cleanroom by patented catalytic converter technology Process air ducts of the air handling unit through the building for outside air handling are not required

10 Aseptic transfer systems for sterile transfer of materials i nto an d out of th e isolator Integrated H2O2 Material Transfer Chamber (MTC) stand alone Material Transfer Chamber Isolator MTC's can be attached anywhere they are needed in the isolator footprint The MTC and the isolator are flushed together with H2O2, therefore no additional decontamination system is needed During production the MTC is served by the decontamination system Tools and monitoring materials can be transported through the MTC without breaking sterility The MTC is served by its own decontamination system Used for the transfer of tools and other materials to an isolator Material transfer chamber with pull-out grid integrated in the isolator design Stand alone material transfer chamber Th e i ntegrated MTC can flexi b ly adapted to th e mac h i n e's design

11 Aseptic transfer systems for sterile transfer of materials i nto an d out of th e isolator Rapid transfer Ports (RTP) Rapid transfer ports allow materials to be transferred into and out of a closed aseptic system by connecting two standardized mating systems with one another Ergonomically designed bag support for stopper transfer ATEC rotating alpha port integrated in the isolator design Rapid Transfer Port and SART Port connections Offset of Rapid Transfer Ports for transfer of material under laminar air flow

12 Aseptic transfer systems for sterile transfer of materials i nto th e isolator Your requirements our solution Surface decontamination of pre-sterilized nested tubs Safe and continuous aseptic transfer of the tubs to the filling line with highest Sterility Assurance Level Low-maintenance and stable process to transfer the tubs into the filling-line Time savings during qualification and validation Compliance with FDA and verifying authorities With an average minimum radiation energy of 25kGy the M+P E-Beam tunnel guarantees surface decontamination of pre-sterilized tubs. The design has been conceived for a continuous, low-maintenance aseptic transfer from class D/C areas into class A filling-line areas. The M+P E-Beam tunnel is qualified and validated as a single unit. Sandwiched lead shielding around electron beam emitters

13 Syringe filling line with automated debagging, E-Beam tunnel and aseptic isolator

14 Decontami nation process You r r equ i r ements Our solution Process according to FDA and cgmp regulations A stable, effective and reproducible decontamination process Execution of Low Level H2O2 concentration analysis DECOjet Utilizing DECOjet improves the H2O2 distribution Reduction of aeration and cycle time H2O2 flow simulations to identify worst case positions Papers Process phases H2O2 Conc. ppm Lower the H2O2 Concentrations in Your Isolator with One Easy Upgrade, PDA Letter, May steps of a reproducible cycle development plan, PDA Letter, June ppm Implementation of catalytic technology to improve aeration process for syringe-filling line isolator, Pharmaceutical engineering, Feb Einen Dekontaminatioszyklus für den Isolator entwickeln, Process Vogel, May 2015 La Vague Advanced vaporized H2O2 decontamination technology for pharmaceutical isolators Jan ppm Conditioning Decontamination Aeration Ready for Production

15 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 Patented H2O2 Decontamination System DECOjet Catalytic converter tec h nology Catalytic Converter Technology to reduce aeration time Continuous reduction of H2O2 takes place during the production phase when air is recirculated across the catalytic converters. This prevents increases in H2O2 concentrations from outgassing effects. Patented arrangement of the catalytic converter in the recirculation plenum Homogeneous H2O2 distribution by way of DECOjet placed near the worst-case positions

16 Metall + Plastic GmbH Bodmaner Straße Radolfzell-Stahringen Germany Phone Fax info@metall-plastic.de Isolator accessori es Glove testing solutions Transparant Glove Ports Visi-Ports One and two piece glove stands Semi-automatic glove exchange device without breaking the sterility Glove stand trolley or wall bracket Measuring instrument for determining the leak rate

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