Sterilization
is key to keeping products, items, articles free of known contamination. One
could choose different modes of sterilization such as moist heat, dry heat,
ethylene oxide, gamma irradiation, filtration etc. The use of moist heat is the
most preferred method in the pharmaceutical manufacturing domains.
Terminal Sterilization
(TS) is the process that involves moist heat sterilization of filled and sealed
products like vials, ampoules, bottles, bags etc. The sterile hold duration setting
for TS products is one of the most critical tasks in the process. Container size and the fill volume are the key
attributes to be considered. A D-value determination (define D-value) helps in
the fixing the sterile hold duration of the products. Sufficient care must be built
into the design of the experiments to ensure that increase or decrease in the
hold time does not affect the quality attributes of the terminally sterilized product.
During the
design and development of TS-cycle where the customer had qualified the cycle
by coupling a physical and biological approach, evaluating the product
attributes post the heat exposure phase depicted an increased impurity level.
An investigation of this problem revealed two aspects,
1. Cycle
designed was based on an over-kill approach
2. D-value
used was 2.5 minutes
We brought
the VieNnI’s
sterilization expertise and experience to the table. Our work and analysis
quickly addressed the situation and the solution was framed.
1.
We suggested that an over-kill
approach was the least suitable for TS products.
2.
We brought clarity to the process
with explanations of the theory and practice of TS.
3.
D-value determination of the TS-product
was performed subsequently which was to the customer’s satisfaction.
4.
Regulatory compliance was ensured.
Adequate justification, to revise the process including the cycle and validation,
development time and cost was made and checked.
We
successfully helped the team in meeting quality acceptance criteria of the product
and its specifications.
If your
sterilization process needs help, if your validation team needs clarity, and if
you want your manufacturing operations to be unhindered by these issues,
experts from Vienni
are just a call away at 91 80 23506562 or email us at vienni.india@gmail.com. Let us design and develop sterilization process and related
solutions for you.
