System Requirements

Generally, Containment systems are applied in order to avoid contamination of the environment by dust and other critical substances.  The systems requirements depend on the products and have to be repeatedly defined for each new project.
Containment levels can be classified with our HECHT pyramid. It shows several classification levels: OEB ( Occupational Exposure Band) and OEL (Occupational Exposure Limit) or TOX (Toxicity). The classification refers to the toxicity of the products and permits to determine the amount of particles per air quantity. Having classified your product, HECHT offers the appropriate solution (depending on you requirements).  Systems then have to be designed with focus on the respective meet the specification level. Basic hygienic design approaches include dead space  free design, closed systems or easy accessibility for cleaning . If you like to know more about the containment systems and solutions from HECHT, then contact us directly. 

System Qualification

Containment systems should be qualified and validated with respect to their tightness and their adequate use in the company. In order to standardize this procedure, the ISPE issued a Good Practice Guide "Assessing the Particulate Containment Performance of Pharmaceutical Equipment“ (APCPPE), better known as SMEPAC, in the year 2004. In the mean time, this document has been established as the standard for measurements of containment systems.
Also the new ISPE containment manual can be a support. HECHT systems have also been measured according to SMEPAC. Our liner connection system for FIBCs or pouches, for example, permits to reach an OEL (Occupational Exposure Limit) of smaller than 1 µg/m³. The same is true for our Expendable Weighing Isolator EWI, the Expendable Powder Sampling system EPS, the containment sack discharge station as well as for our drum filling station with continuous liners.
Besides, HECHT actively participates in the revision of the APCPPE Good Practice Guides. 

Overall View

Containment systems are particularly applied within the areas of pharmaceutical- (drug and API manufacturers), food- (high-quality food, baby food, nutraceuticals and enzymes) and chemical industries (fine chemicals, biotech, colour and lacquer manufacturers, etc.).
They all have in common that especially purity, safety and avoidance of cross-contamination loom large.
Let us focus on one major point:
It is importantthat always the complete process including all relevant sections and components is considered and not only an isolated solution itself.
This starts with the incoming goods and ends not until maintenance and services.
Therefore, Containment systems only make sense as soon as single process steps are integratively connected and the risks of contamination particularly at the interfaces are minimized or eliminated respectively. 

Dead-space-free construction
Dead-space-free construction
Hygienic Design
Hygienic Design
SMEPAC with the customer on-site
SMEPAC with the customer on-site
Overall View
Overall View

Hecht Technologie GmbH

Schirmbeckstr. 17
D-85276 Pfaffenhofen

T: +49 8441 - 8956 - 0
F: +49 8441 - 8956 - 56

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