LAB CONTAINMENT TECHNOLOGIES The Economical Containment Solution for Labs

Glatt. Integrated Process Solutions.

LAB CONTAINMENT TECHNOLOGIES – MAXIMUM EFFICIENCY IN THE LAB Deal with Containment Requirements as needed High-potency substances require highly efficient 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 Requirements Basically there are five 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, different barrier systems were used for different requirements depending on the containment level. An expensive endeavor.

Containment-Levels by Traffic 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 five.

OEL (Operator Exposure Limit) μg/m3

OEB (Operator Exposure Band) μg/m3

The efficient Solution for flexible Containment Requirements In order to meet the demand for cost-optimized containment solutions for different 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.

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LAB CONTAINMENT SOLUTIONS Less is more: One System for many Requirements Thanks to this intelligent lab containment technology, it is now possible to run several consecutive lab processes with

One barrier system for total containment-flexibility across the board

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

» Weighing

» Mixing

for granulation can be realized with just one WIBObarrier®

» Granulating

» Tableting

system equipped with lab containment technology by Glatt.

» Sieving

» Coating

The respective WIBObarrier® system can be variably expan-

» Drying

ded depending on the OEB level and the actual application.

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

separates it from the environment and the operating

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

personnel. The device’s control system is located outside

be efficiently and flexibly moved into the clean room area,

the WIBObarrier® system, which significantly minimizes

if required. This means the clean room zone is significantly

the subsequent need for cleaning. The use of proven

minimized and only exists where it is actually needed. We

WIBObarrier® system components combined with new lab

recommend assigning a separate table to each process. A

containment technologies significantly reduces

seal automatically fixes the table within the clean room area.

expenditures, because the generally necessary safeguards

During the process, adjustable nozzles and targeted air

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

extraction create a „barrier curtain“ consisting of clean source

barrier systems at the same time in order to increase

air, which circulates around the product and effectively.

process efficiency.

Individual Advice for individual Requirements When 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 specific 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 find the perfect containment solution for your specific needs.

Your Benefits

PSA (Personal Safety Application)

» Efficient cleaning as the technology module is separate » Minimum operating and investment costs due to reduction to just one barrier system with a small footprint

Costs

from the processing unit

» Easy reconfiguration of the existing infrastructure » Maximum flexibility in terms of process options and containment levels low frequency

Application

high frequency

Glatt. Integrated Process Solutions. 3

LAB CONTAINMENT TECHNOLOGIES – MAXIMUM PROCESS FLEXIBILITY Unlimited Possibilities for any Requirement WIBObarrier® systems with lab containment technology by Glatt are available in three different versions and offer various combination and configuration possibilities – customized for every process. 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.

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

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Glatt. Integrated Process Solutions. 5

LAB CONTAINMENT TECHNOLOGIES – MAXIMUM PROCESS INTEGRATION A safe Solution across the Board This 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

Weighing

Blending

Flexible weighing systems and precision

CML – our flexible container mixer with

scales

exchangeable containers from 2.5 to 10 liters

0,000 g

Granulating

Tablet processing

TMG – our efficient high-shear mixer and

Tableting

wet granulator for product volumes from 0.1 to 4.5 liters Sieving

Coating

GSF – our multifunctional sieving talent for

GC 1 – our efficient drum coater with a work

wet products with a volume from 0.1 to 30

volume from 0.8 to 2.5 liters

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

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EXCELLENT PARTNERSHIP FOR EXCELLENT SOLUTIONS Pooled Know-How for Top Results Weiss Pharmatechnik (formerly Weiss GWE) develops and manufactures 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.

Expertise in Development – Glatt. Pharmaceutical Services.

The FDA- and EMA-certified pharmaceutical services offered by Glatt provide comprehensive expertise for development

Take Advantage of comprehensive Advice for containment-related Questions:

procedures as well as vast practical experience for the processing of the most varied of drug classes. We can support

»» Quality assurance

you with advice concerning risk analyses and help you select

»» Prevention of cross-contamination

the appropriate system combination. Custom-fit for your

»» Selection of the best cleaning procedures

requirements.

»» Cleaning verification and validation »» Training on various containment topics

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