LAB CONTAINMENT TECHNOLOGIES

The Economical Containment Solution for Labs

Glatt. Integrated Process Solutions.

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LAB CONTAINMENT TECHNOLOGIES – MAXIMUM EFFICIENCY IN THE LAB

Deal with Containment Requirements as neededHigh-potency substances require highly effi cient protective measures for product, people, and the environment. Given the

increased use of active and toxic substances, the legal provisions for protective measures issued by the EMA and FDA are

also getting tougher – whether in terms of more product safety during processing or reliable operator protection. Demanding

containment requirements are particularly challenging when it comes to system engineering. But is high containment, i.e.,

strict isolation necessary for every application?

The higher the OEB level, the higher the Protection RequirementsBasically there are fi ve containment levels. The following golden rule applies: If the OEB level is above three, an isolator should

be considered and possibly evaluated by means of a risk analysis. If the OEB level is above four, total containment is mandatory.

In other words: Up until now, diff erent barrier systems were used for diff erent requirements depending on the containment

level. An expensive endeavor.

The effi cient Solution for fl exible Containment Requirements In order to meet the demand for cost-optimized containment solutions for diff erent OEB levels in the lab, we have developed

an innovative technology which we have implemented in cooperation with the barrier manufacturer Weiss Pharmatechnik:

Lab Containment Technologies.

Containment-Levels by Traffi c Light Principle:

OEL – Operator Exposure Limit describes

the average concentration of the

active substance in μg/m3 within the

operator’s breathing zone over a period

of eight hours.

OEB – Operator Exposure Band indicates

the toxicity level of the substance on a

containment scale from one to fi ve.

OEL (Operator Exposure Limit) μg/m3 OEB (Operator Exposure Band) μg/m3

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Glatt. Integrated Process Solutions.

Less is more: One System for many RequirementsThanks to this intelligent lab containment technology, it is

now possible to run several consecutive lab processes with

just one barrier system. For example, an entire process chain

for granulation can be realized with just one WIBObarrier®

system equipped with lab containment technology by Glatt.

The respective WIBObarrier® system can be variably expan-

ded depending on the OEB level and the actual application.

That is how economical Containment worksEach lab processing unit or a suitable combination of two

processing units is located on a mobile work table, which can

be effi ciently and fl exibly moved into the clean room area,

if required. This means the clean room zone is signifi cantly

minimized and only exists where it is actually needed. We

recommend assigning a separate table to each process. A

seal automatically fi xes the table within the clean room area.

During the process, adjustable nozzles and targeted air

extraction create a „barrier curtain“ consisting of clean source

air, which circulates around the product and eff ectively.

separates it from the environment and the operating

personnel. The device’s control system is located outside

the WIBObarrier® system, which signifi cantly minimizes

the subsequent need for cleaning. The use of proven

WIBObarrier® system components combined with new lab

containment technologies signifi cantly reduces

expenditures, because the generally necessary safeguards

are no longer needed. It is even possible to use two

barrier systems at the same time in order to increase

process effi ciency.

LAB CONTAINMENT SOLUTIONS

One barrier system for total containment-fl exibility across the board

» Weighing

» Granulating

» Sieving

» Drying

» Mixing

» Tableting

» Coating

Your Benefi ts » Effi cient cleaning as the technology module is separate

from the processing unit

» Minimum operating and investment costs due to

reduction to just one barrier system with a small footprint

» Easy reconfi guration of the existing infrastructure

» Maximum fl exibility in terms of process options and

containment levels

Individual Advice for individual RequirementsWhen it comes to production requiring containment, potential investment options must already be considered before the

plant is selected. Because only a thorough analysis of the specifi c parameters will lead to the perfect solution. Important factors

that go into the decision-making process are the general conditions on the one hand, as well as the frequency of containment

product cycles on the other. We will support you with our extensive know-how and many years of experience in order to fi nd

the perfect containment solution for your specifi c needs.

PSA (Personal Safety Application)

Applicationlow frequency high frequency

Cost

s

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The WIBObarrier® OCS (Open Containment System) is an

ergonomic work place for the protection of personnel, room,

and products with integrated clean room zone up to OEB 4.

Despite the gentle air flow, its air guidance system ensures a

solid retention capacity when the front is open up to a height

of 1,000 mm.

The WIBObarrier® OCSplus (Open Containment System with

protective pane) can be equipped with a horizontally movable

glass pane that serves as splash and cross-contamination

protection. The sliding pane is fitted with glove ports to enable

ergonomic working. The WIBObarrier® OCSplus can protect

personnel and room up to level OEB 4 / OEB 5.

The WIBObarrier® CCS (Closed Containment System) with

closed front window can be categorized as a closed safety

workplace, similar to isolators and RABS systems. It achieves

personnel and room protection up to OEB 5. If less dangerous

substances are being processed, the front window can be

swiveled out or folded up, allowing for the WIBObarrier® to be

used without obstacles.

LAB CONTAINMENT TECHNOLOGIES – MAXIMUM PROCESS FLEXIBILITY

Three different Versions are available:A) Basic level: Open system OCS

B) Plus level: Open system OCSplus with sliding pane

C) High level: Closed system CCS

Unlimited Possibilities for any RequirementWIBObarrier® systems with lab containment technology by Glatt are available in three different versions and offer various

combination and configuration possibilities – customized for every process.

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Glatt. Integrated Process Solutions.

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Blending

CML – our flexible container mixer with

exchangeable containers from 2.5 to 10

liters

Tablet processing

Tableting

Coating

GC 1 – our efficient drum coater with a work

volume from 0.8 to 2.5 liters

Weighing

Flexible weighing systems and precision

scales

Granulating

TMG – our efficient high-shear mixer and

wet granulator for product volumes from 0.1

to 4.5 liters

Sieving

GSF – our multifunctional sieving talent for

wet products with a volume from 0.1 to 30

kg/h

Drying

Mini-Glatt / Midi-Glatt – our lab classic for

drying, granulating, and coating with a work

volume of 2.5 to 375 grams

LAB CONTAINMENT TECHNOLOGIES – MAXIMUM PROCESS INTEGRATION

0,000 g

A safe Solution across the BoardThis lab containment technology is a multi-talent meeting all requirements for effective protection of product, personnel and

room, and works for all process options and systems. On request, we can implement a flexible workplace, customized to your

requirements.

You are always on the safe Side with our flexible Process Technology

OCS - Our open containment system with clean air curtain

OCSplus - Our open containment system with clean air curtain and sliding pane

CCS - Our closed total containment system with clean air curtain and closed front pane

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Glatt. Integrated Process Solutions.

Weiss Pharmatechnik (formerly Weiss GWE) develops and manu-

factures GMP- and FDA-compliant systems and safety workplaces

to collect and extract contaminants for the protection of products,

personnel, and rooms. Its proven WIBObarrier® systems offer the

perfect design for the integration of our innovative lab containment

technology.

EXCELLENT PARTNERSHIP FOR EXCELLENT SOLUTIONS

Pooled Know-How for Top Results

The FDA- and EMA-certified pharmaceutical services offered

by Glatt provide comprehensive expertise for development

procedures as well as vast practical experience for the pro-

cessing of the most varied of drug classes. We can support

you with advice concerning risk analyses and help you select

the appropriate system combination. Custom-fit for your

requirements.

Take Advantage of comprehensive Advice for containment-related Questions:

» Quality assurance

» Prevention of cross-contamination

» Selection of the best cleaning procedures

» Cleaning verification and validation

» Training on various containment topics

Expertise in Development – Glatt. Pharmaceutical Services.

© Glatt GmbH. All rights reserved. Subject to errors and technical changes. BRO_PTPH_082_Lab_Containment_Tech_2016_04_EN. Glatt Corporate Marketing.

www.glatt.com