38 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2020 P h a r mTe c h . c o m
Operations
P
harmaceutical Technology spoke with Richard Denk, senior
consultant aseptic processing and containment, SKAN AG,
about the risks of contamination in biopharmaceutical
manufacturing and how this risk can be mitigated.
Contamination issues
PharmTech: What types of contamination can occur in biopharma-
ceutical manufacturing?
Denk (SKAN): In biopharmaceutical manufacturing, [there] are many
risks of contamination such as microbiological contamination; par-
ticle contamination from fibers, skin, surfaces, etc.; contamination
from cleaning agents; and/or contamination from different products
produced before in the room. As I'm focused in aseptic processing,
the contamination control strategy (CCS) for Grade A /ISO 5 and
sourrounding is our major focus. In this area, we are focusing on
the critical aseptic zone and the transfers of material, tools, etc., in
the critical aseptic zone.
PharmTech: Where in the manufacturing process is product most
vulnerable to contamination?
Denk (SKAN): Open process and direct access to critical open opera-
tions are the highest risk of contamination. This means, especially
for aseptic processing, the filling of the container (e.g., vials, sy-
ringes, etc.) and the following steps like stoppering and lyophiliza-
tion (if part of the process) until the container is sealed [are crucial].
Beside the open sterile product, each transfer from a lower clean-
room grade into the Grade A area is critical for contamination. For GORODENKOFF
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STOCK.ADOBE.COM
Considerations in
Contamination Control
Susan Haigney
A contamination control
strategy can prevent
contamination in sterile
product manufacturing. The
right system, equipment, and
personnel training are also
essential to mitigate risk.