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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.

 

Shang Mei Unt Packing Co.,Ltd.
No. 31, Shiangyun St., Shijr City, Taipei, Taiwan.
Tel: +886-2-2646-1992 Fax: +886-2-2646-1991
E-mail: shangmei@bizmail.com.tw URL: www.shangmei.com.tw
Jenq Yi Lan Enterprise Co., Ltd.
No.20, Lane 351,FU-TEH FIRST ROAD,HSI-CHIN CITY, TAIPEI COUNTY,TAIWAN
Tel:+886-2-2694-6098 Fax:+886-2-2694-0318
E-mail: jenqyi@bizmail.com.tw URL: www.jenqyi.com.tw

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