|
Cleaning Validation
Capabilities
|
Cleaning Validation
PharmaSys has extensive experience in developing
and executing cleaning validation
programs in multi-product
facilities.
We understand the challenges
of ensuring a consistent and
effective cleaning program in high
throughput facilities.
Cleaning validation ensures
that specific cleaning processes
consistently clean residuals to pre-defined
limits of acceptability (product or cleaning
chemistry related) based on a scientifically
based methodology.
A good cleaning validation program
will provide documented evidence that
residuals from previous processing and
cleaning do not adulterate and adversely
affect the safety and quality of the next
product manufactured.
Our highly skilled team can help your
organization ensure that equipment cleaning
procedures are removing residues to pre-defined
levels of acceptability. We
can deliver a complete package from development
and execution of engineering studies and
protocols, to creation of cleaning matrices,
swab rationales, cleaning procedures, equipment
cleaning and use logs, and training
documentation.
|
Simplify your cleaning validation program
Complete
understanding of FDA
requirements, guidelines and
expectations.
Selection and
evaluation of effective cleaning
methods and processes.
Establishment
of residue limits and calculation
sample acceptance criteria.
Selection of
sampling and analytical methods.
|