PHARMACEUTICAL PRODUCTION ISOL ATORS FOR ASEPTIC / ASEPTIC-TOXIC FILLING

A company for the designand manufacture ofcleanroom equipment

PHARMACEUTICAL PRODUCTION ISOLATORS FOR OPERATOR,

ENVIRONMENT AND PRODUCT PROTECTION

METALL+PLASTIC

Our isolators are designed and manufactured to be cGMP-

compliant enabling a fast and safe transfer of materials

into and out of the containment area.

YOU R R EQU I R EMENTS

You need a partner whose knowledge and technical exper-

tise meets your filling process requirements for stability

and reproducibility. Our solutions provide product and user

protection, along with fast and reproducible decontamina-

tion processes.

ASEPTIC - NON TOXIC

Product protection

Double wall design

Isolator leak rate < 5% *

Manual wipe down

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

ASEPTIC - TOXIC

Product & operator protection

Single wall design

Isolator leak rate < 3% *

Manual wash down + automated CIP of return air duct

OU R SOLUTION

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.

* Depending on requirements

METALL+PLASTIC

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

SOLUTIONS FOR YOUR ASEPTIC FI LLING PROCESS

DOUBLE 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.

METALL+PLASTIC

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 automati-

cally 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

Supply / Return ducts

Exhaust air Supply Air

Interstitial space

Grade C / D cleanroom

Cleanroom ceiling

Manipulation unit

Filling Machine, Lyo Loading / Unloading

HVAC (Heating, Ventilation and Air

conditioning)

Technical area

Air recirculation

Continuous double return wall design Easy cleaning of the inner panes Pneumatic sealed doors made of safety glass

and removable return flow grids

Turnkey line covering all interfaces for an aseptic production isolator

METALL+PLASTIC

SOLUTIONS FOR YOUR ASEPTIC FI LLING PROCESS

SINGLE 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 pro-

tection 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 deconta-

minated using our patented DECOjet® system.

METALL+PLASTIC

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 / Return ducts

CIP spray balls

Supply air

Filter Fan Unit

Interstitial space

Grade C / D cleanroom

Manipulation unit

Sloped machine base plate

Filling machine, Lyo Loading / Unloading

HVAC (Heating, Ventilation

and Air conditioning)

Technical area

BiBo-Filter

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

METALL+PLASTIC

Turnkey line covering all interfaces for an aseptic - toxic production isolator

SOLUTIONS FOR INDIVIDUAL AIR HANDLING CONCEPTS

METALL+PLASTIC

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-conditio-

ning concept. Filters ensure the necessary cleanliness of

the incoming and outgoing air.

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

AI R HAN DLI NG CON EPT FOR OUTSI DE AI R

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

METALL+PLASTIC

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

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

AI R HAN DLI NG CONC EPT PR E-CON DITION ED AI R PROC ESS AI R FROM TH E C LEAN ROOM

AN D R ETU R N TO TH E C LEAN ROOM

METALL+PLASTIC

STAN D ALON E MATER IAL TRANSFER C HAMB ER

The MTC is served by its own decontamination system

Used for the transfer of tools and other materials to

an isolator

I NTEGRATED H2O2 MATER IAL TRANSFER C HAMB ER (MTC)

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 deconta-

mination system

Tools and monitoring materials can be transported

through the MTC without breaking sterility

ASEPTIC TRANSFER SYSTEMS FOR STERILE TRANSFER OF MATERIALS

INTO AND OUT OF THE 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

METALL+PLASTIC

RAPI D 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

METALL+PLASTIC

ASEPTIC TRANSFER SYSTEMS FOR STERILE TRANSFER OF MATERIALS

INTO AND OUT OF THE ISOLATOR

Ergonomically designed bag support for stopper transfer

Rapid Transfer Port and SART Port connections “Offset” of Rapid Transfer Ports for transfer of

material under laminar air flow

ATEC rotating alpha port integrated in the isolator

design

OU R SOLUTION

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.

YOU R R EQU I R EMENTS

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

ASEPTIC TRANSFER SYSTEMS FOR STERILE TRANSFER OF MATERIALS

INTO THE ISOLATOR

Sandwiched lead shielding around

electron beam emitters

METALL+PLASTIC

METALL+PLASTIC

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

DECONTAMINATION PROCESS

METALL+PLASTIC

YOU R R EQU I R EMENTS

Process according to FDA and cGMP regulations

A stable, effective and reproducible decontamination

process

Execution of Low Level H2O2 concentration analysis

OU R SOLUTION

DECOjet ®

Utilizing DECOjet ® improves the H2O2 distribution

Reduction of aeration and cycle time

H2O2 flow simulations to identify worst case positions

PROC ESS PHASES

H2O2 Conc. ppm

800 ppm

1 ppm0

Conditioning Aeration Ready for ProductionDecontamination

PAPERS

“Lower the H2O2 Concentrations in Your Isolator

with One Easy Upgrade”, PDA Letter, May 2017

“7 steps of a reproducible cycle development plan”,

PDA Letter, June 2016

“Implementation of catalytic technology to

improve aeration process for syringe-filling line

isolator”, Pharmaceutical engineering, Feb. 2016

“Einen Dekontaminatioszyklus für den Isolator

entwickeln”, Process Vogel, May 2015

“Advanced vaporized H2O2 decontamination

technology for pharmaceutical isolators” Jan. 2017

34 I La Vague 

TECHNO/PROCESS

!

METALL+PLASTIC

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

I NTEGRATED H2O2 DECONTAMI NATION 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®

METALL + PLASTIC GmbH

Bodmaner Straße 2

78315 Radolfzell-Stahringen

Germany

Phone +49 77 38-92 80 - 0

Fax +49 77 38-92 80 - 10

info@metall-plastic.de

www.metall-plastic.de

ISOLATOR ACCESSORIES

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