12 Pharmaceutical Technology
®
Trends in Manufacturing eBook May 2023 PharmTech.com
Biologics
the necessary experience and expertise to minimize
risk and navigate essential regulations.
References
1. BlueWeave Consulting, Aseptic Pharma Processing
Equipment Market Projected to Touch Market Worth USD
12.9 Billion: Growing at a CAGR of 7.2% in the Forecast Pe-
riod | BlueWeave Consulting. Press Release, July 18, 2022.
2. Virtanen, S.; Kapp, K.; Rautamo, M. Compounding
Parenteral Products in Pediatric Wards-Effect of En-
vironment and Aseptic Technique on Product Sterility.
Healthcare (Basel). 2021, 9 (8), 1025. DOI: 10.3390/
healthcare9081025
3. FDA, Guidance for Industry, Sterile Drug Products Pro-
duced by Aseptic Processing—Current Good Manufac-
turing Practice (CDER, CBER, October 2004).
4. E M A , E M A/C H M P/C V M P/QW P/8503 74/2015 ,
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uct, Active Substance, Excipient and Primary Container
(March 6, 2019).
5. R i v e r s , M . Au t o m a t i n g A s e p t i c P r o c e s s i n g
Reduces Contamination Risk. Pharm. Technol. 2022,
46 (6), 16–18, 21.
6. FDA, Warning Letter: Sun Pharmaceutical Industries
Ltd. fda.gov, Dec. 15, 2022
7. FDA, Warning Letter: Optum Infusion Services 308
LLC. fda.gov, Dec. 13, 2022.
8. Ong, K. L.; White, J.; Swanis, E.; Tucker, S. D. Under the
Watchful Eye: What Do FDA Warning Letters Tell Us?
theclm.org, Aug. 6, 2014.
9. Jane, S. Pfizer's Newest Vaccine Plant Has Persistent
Mold Issues, Histor y of Reca l ls. tampabay.com,
March 10, 2021.
10. Reuters, FDA Warns Pfizer Over Contaminated Drugs
at Kansas Plant. reuters.com, Feb. 28, 2017. ■
More on Aseptic Processing
For more on aseptic processing in bio/pharma
manufacturing, read these articles on PharmTech.com:
• Improving Sterility Using Blow-Fill-Seal Technology
www.PharmTech.com/view/improving-sterility-us-
ing-blow-fill-seal-technology
• Automating Aseptic Processing Reduces
Contamination Risk
www.PharmTech.com/view/automating-aseptic-pro-
cessing-reduces-contamination-risk
• The Basics of Aseptic Processing
www.PharmTech.com/view/the-basics-of-asep-
tic-processing
• Considering Blow-Fill-Seal for Biologic Drugs
www.PharmTech.com/view/consider-
ing-blow-fill-seal-for-biologic-drugs
Patrick Nieuwenhuizen,
Director Senior Consultant,
PharmaLex Ireland
The Criticality of
Training in Aseptic Processing
Just how important is training for aseptic
processing? Human error is one of the
biggest pitfalls for contamination in aseptic
processing, and the proper training of staff
continues to be of the utmost importance. In
this Drug Solutions Podcast episode, Patrick
Nieuwenhuizen, director senior consultant,
PharmaLex, shares how important training is
for aseptic processing.
In Pharmaceutical Technology
®
's Drug
Solutions Podcast, the editors interview industry
experts from across the pharmaceutical and
biopharmaceutical supply chain on a variety of
bio/pharma related topics.
For more podcast
episodes, visit our website!
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