S. SINCLAIR and ALAN TALLENTIRE,
Evaluation of Blow/Fill/Seal Extrusion
through Processing Polymer
Contaminated with Bacterial Spores and
Endotoxin. PDA Journal Vol. 58, No. 3,
3. STEFAN SUNDSTROM, AIRBORNE
CONTAMINANTS IN THE
ENVIRONMENT. Bulletin No. 75, KTH,
Royal Institute of Technology, Stockholm,
Sweden, September 2010
4. PATRICK POISSON, COLIN S. SINCLAIR,
ALAN TALLENTIRE, Challenges to a
Blow/ Fill/Seal Process with Airborne
Microorganisms having Different
Resistances to Dry Heat. PDA Journal Vol.
58, No. 3, May-June 2004
5.Iacocca RG, Toltl N, Allgeier M, et al.
Factors affecting the chemical durability of glass used in the pharmaceutical
industry. AAPS PharmSci Tech. 2010;
11( 3):1340–1349. DOI 10.1208/s12249-010-
6. USP <1660> EVALUATION OF THE
INNER SURFACE DURABILITY OF GLASS
Commercial sizing is based on yearly production requirements, the container design
and any sterile inserts that are required.
Common inserts include tip and cap for
multi-dose ophthalmic containers and elastomer septum for injection product vials.
BFS machines have very high OEE so sizing
accuracy is reliable.
Blow/Fill/Seal is celebrating its 50th anniversary with new applications and continued improvements. High aseptic assurance,
reliability and cost effectiveness have moved
Blow/Fill/Seal onto the list for new product
packaging consideration. ■
1. Guidance for Industry Sterile Drug
Products Produced by Aseptic Processing
— Current Good Manufacturing Practice,
U.S. Department of Health and Human
Services Food and Drug Administration
Center for Drug Evaluation and Research
(CDER) Center for Biologics Evaluation
and Research (CBER) Office of Regulatory
Affairs (ORA) September 2004, pp. 49-51
2. FRANK LEO, PATRICK POISSON, COLIN
HVLD is also limited to products that have
some conductivity. Vacuum systems can check
the entire container and are not dependent on
conductivity. Detection on containers filled with
products that can plug holes could be difficult.
Particle inspection is typically performed
with the traditional visual inspection by personnel method. Recent advances in inspection
technology have enabled BFS containers to be
inspected by an automated system. Existing
particle inspection systems work best on
glass containers that can be spun. Do to the
BFS container characteristics this system did
not work well. The new Particle Inspection
Machine (PIM) inspection system vibrates the
container with a standing wave while taking
multiple pictures. The system then identifies
the particle by its movements (or lack of).
Common secondary packaging systems include marking (ink jet and tampo print), labeling,
foil overwrapping, and cartoning. Overwrapping
is used to provide barriers to gas and light per-meation and to extend shelf life.
PSG Grand Terrace
22069 Van Buren Street
Grand Terrace, CA 92313-5607
O: +1 (502) 905-9169
F: +1 (909) 783-3440
When it comes to meeting increasingly risk-based containment regulations, accept no substitutes.
• CIP (Clean in Place) and SIP (Sterilize in Place)
• No product entrapment areas
• Self-priming, run dry and have negative suction lift
• Pro-Flo X™ Air-Distribution System (ADS) reduces energy costs
• Full Stroke PTFE Integral Piston Diaphragms for superior product containment
Contact your Wilden authorized distributor today at www.wildendistributor.com