Containment Systems: Different Concepts For The Levels OEB1 To OEB5

The production of Active Pharmaceutical Ingredients (APIs) increasingly requires the implementation of prevailing directives such as the ICH Q7A, which by now has strengthened its importance by being incorporated as Annex 18 in the EC GMP Guide. Equally important, however, is the implementation of the improvement for human safety in the production of Intermediates and APIs.

Collective Safety Measures (closed systems) before Personal Protective Equipment (PPE)

This not merely is a lawful claim by the EU Guideline 89/391 EEC but even the new Act for Hazardous Goods (www.baua.de) demands collective safety measures (closed systems). For the effective operator safety, it is paramount to enclose the product at the location where it is produced and to maintain such enclosed condition from the first step of the process until the product’s final packaging. Often, a critical phase emerges while changing processing facilities and transportation receptacles (containers, drums, sacks or Big Bags). If transports become indispensable, an OEL-/OEB classification is undertaken (determination of Workplace Boundaries) in order to select the appropriate transfer system. (OEL-/OEB mean Operator Exposure Limit/Band; see box).

As soon as OEL-/OEB values of a new API and/or Workplace Boundaries for chemical products have been determined, the technical effort involved can be defined with the effect to keep investment- and operating costs at a minimum. Hecht Anlagenbau GmbH has developed systems for all OEL-/OEB levels (Workplace Boundaries) and all major transportation receptacles.