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Double-Redundant and Fail-Safe Design for liquid packing machine
When you properly apply the liquid packing machine,
double-redundant and fail-safe design methods focus validation practices
on machine enhancement and reliability, reducing dependence on operator
vigilance and intervention.
Validation has been an FDA-mandated requirement in the medical device
industry for many years. At first, the regulation caused immense
confusion, and the initial focus by many was on generating documentation.
As the practice of validation has advanced, however, a greater emphasis
has been placed on the process of validating machinery and equipment.
The art of
liquid
packing machine validation continues to develop and expand. As the
validation testing and qualification processes mature, a greater
understanding of manufacturing risks emerges. One aspect, positive,
fail-safe machine design, has always been a feature of good manufacturing
practices (GMPs). But as the technology of processing and packaging
machinery advances, there is now a greater risk of failure and a
correspondingly greater challenge to design fail-safe systems.
The regulatory bodies continue to be vigilant where customer's lives may
be threatened. This vigilance is particularly important where the customer
has to place absolute trust in the product. For example, ensuring product
and package integrity is critical in cases of packaging where information
essential to identifying the product is included on the package—or in the
case of sterile products, where the packaging is part of the product.
In the medical manufacturing industry, the consumer has no alternative but
to place absolute faith in the package and the product. Errors such as
packaging mix-ups or faulty packs that lead to nonsterile products can
easily go undetected by the consumer. Such a high level of consumer trust
in the product places a high responsibility upon the manufacturer—a
reliance that can only be met through GMPs, process and product controls,
and process validation.
Validation has been an evolutionary process for most companies in the
medical device industry. Firms have generally taken a responsible stance
in implementing validation, thereby ensuring the robustness of their
processes, packs, and products. A large number of companies have followed
guidelines on testing and qualifying packaging machines, and there is no
doubt that the validation process has substantially improved the design,
quality, and performance of such machines and
liquid
packing machine processes.
In the drive for near-zero defects and the need for absolute control of
the packaging process, however, questions are being raised regarding
faults that occur at a very low and unpredictable frequency of any
liquid
packing machine. Such undetected faults are aberrations that are
more likely to occur today as a result of technology advances. This is an
liquid packing machine issue of grave concern, because such faults
potentially impact the integrity of the
liquid
packing machine —and therefore, the liquid packing machine
product.
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