Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 43
generally require four to six hours. The aseptic
SBV also makes it possible to downgrade the
surrounding cleanroom environment because of
the integrity of the approach, again generating
further time and cost savings.
Conclusion
The key to advanced aseptic processing is the
elimination and absolute control of all sources
of contaminants, including human-generated
contaminants. The selection of an appropriate
barrier containment technique will be dependent
on several factors, including the requirements of
indiv idua l ma nufacturing faci lities a nd t he
types of products being processed. Choosing the
right contamination control platform requires
considerable research into what a product needs
for an effective process design.
While ease of decontamination and a high
degree of steri lit y assura nce ca n be readi ly
achieved using isolators, RABS bring increased
operational f lexibility and speed of changeover
which appeals to manufacturers that need to adapt
to varying requirements from different customers.
Aseptic SBV technology not only complements
and works in harmony w it h t hese solutions,
but can, in many circumstances, eliminate the
need for other methods.
For manufacturers who require high-speed
com mercia l ma nu fac t u re, ba r r ier isolat ion
technolog ies may ma ke business sense. For
smaller batch sizes, a more f lexible RABS solution
may be more suited to the process.
Reference
1. ISO 14644-7: Cleanrooms and Associated Controlled
Environments—Part 7: Separative Devices (Clean Air Hoods,
Gloveboxes, Isolators, and Mini-Environments) (2004),
www.iso.org/obp/ui/#iso:std:iso:14644:-7:ed-1:v1:en. PT
The split butterfly valve
approach offers manufacturers
a closed handling method that
reduces the resource associated
with cleaning and validating
large areas and minimizes the
need for manual intervention,
all while achieving the necessary
sterility assurance level.
For more on aseptic manufacturing, please visit
PharmTech.com to read the following articles:
• Considerations for Seals in Split Butterfly Valves
Materials used in the seals of split butterfly valves
for aseptic pharmaceutical manufacturing should be
chosen carefully.
www.pharmtech.com/considerations-
seals-split-butterfly-valves
• Moving to Closed Systems for Aseptic Processing
Alternatives to time-consuming, error-prone
operations promise to reduce vaccine manufacturing
costs and improve facility flexibility.
www.pharmtech.com/moving-closed-
systems-aseptic-processing
• Preventing Contamination
During Sterile Powder Transfer
A chlorine dioxide sterilization cycle was developed
for a novel split-valve aseptic powder transfer device.
www.pharmtech.com/preventing-contamination-
during-sterile-powder-transfer
• Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory
Compliance Associates, discusses how to ensure sterility
when manufacturing small-scale parenteral batches.
www.pharmtech.com/ensuring-sterility-
small-scale-production-0
RELATED ARTICLES
