Validation of Aseptic Cleanrooms
for Co-Packing Food Items k n Food It
How do I build a credible and stable validation process?
he recent revisions of the GFSI (Global Food Safety
Initiative) standards and the FDA rulings to implement
the Food Safety Modernization Act have increased the
requirements for controlled environments to prevent
contamination of high risk foods and high care areas. An aseptic
cleanroom is a very controlled environment and is sometimes
used in the food industry especially in aseptic filling of liquids.
You will want to consult with several cleanroom design/build
construction companies to get their proposals for building
an aseptic cleanroom to your specifications as well as the ISO
14644 and IEST industry standards. The recent revisions to the
standards also require validation and verification of the manufacturing processes for high risk foods in high risk areas.
tent and reproducible. Further, a validated process is credible
and stable, because the acceptance criteria have already been
specified in the qualification stages of validation.
If the specifications of the system, how it is designed, and
how it is to operate are known, then it becomes possible to
maximize the performance of that system. If validation is
performed properly and with the right objectives, it can be a
value-added process for the company.
Who is responsible for validation?
The FDA has stated that the facility using the system is totally
What is validation?
Validation in the manufacturing world is the establishment of
documented evidence. The data derived from rigorous testing,
which results in a high degree of assurance that a specific process
or system will consistently meet a predetermined specification or
set of quality attributes, is the documented evidence required for
validation. The validated process creates a validated product.
Similar to what the FDA has mandated in the pharmaceutical,
bio-pharmaceutical, and medical device industries, the food
manufacturing industries are being required to validate the
manufacturing processes of high risk foods to ensure that all
of the systems have a consistent high level of assurance to produce a product that consistently meets its pre-designed specifications. This gives a company a control system that is consis-
Validation Master Plan
– Table of Contents
– Project Purpose and Scope
– Facility Specifications
– Descriptions of Systems and Equipment
– Standard Operating Procedures
– Schedule (with benchmarks)
– Acceptance Criteria