Why Impulse Sealer Standards are Important

Regulations in any industry can not only help the end user feel they are purchasing and using a safe and quality product,but also help the manufacturer confidently market their business as one that steadfastly adheres to all the established protocols and standards of operation in the industry.

While regulating an industry and setting standards does not 100% guarantee all companies are meeting all requirements 100% of the time, without any regulation, workers at the plants and consumers of the products are at risk for experiencing personal health and safety concerns. Thus, the necessity of and adherence to industry standards is critical to the well being and success of any company owner, the employees, and the consumers.

The sealer industry is no exception.

Perfect seals are the end result of the exact alignment of time, temperature, and pressure. While established standard test methods measure the strength of heat sealers, package testing is used to determine the sealed package’s ability to withstand pressure. Other sealer standards are set in place to determine the ability of a sealed package to retain its integrity, sterility, and barrier characteristics. Sealer regulations include the quality management systems of HACCP, statistical process control, and various ISO protocols that are used to ensure that all industry standards are consistentlyused and the final product passes all quality assurance tests.

With its top two users – medical companies requiring individual medication and sterile device packaging, and the food industry requiring sealed and safe storage of fish and seafood, confectionery items, and most other foods being transported or shelved for any period of time –it’s immediately apparent that the establishing, implementing, and adhering to high standards and regulations in the impulse sealer industry is important.

Sealer regulations acknowledge that packaging plays a critical role in ensuring that medical devices, instruments, and medications are sterile from the point of manufacture to the point of use.

If the seal closures of a medical package are compromised in any way, product contamination is certain to arise at some point between shipping, storage, and use. Contamination of a once-sterile and preserved single-use medical product profoundly poses a serious danger and/or life-threatening infection to the end user. Sealer regulations are in place to (ideally) completely eliminate this risk.

All the steps involved in the sealing process must thus be monitored, measured, controlled, validated, and in strict adherence to all the established industry regulations. The integrity of the product and the safety of the end user are depending upon this. Further, the equipment used in the sealing process must also adhere to industry standards so that the process can be consistently repeated to produce a final product in sync with all predetermined standards.

ISO 11607, Part 2 is the relevant regulatory standard for validation of the sealing process for medical applications. This standard details the requirements for not only the forming and sealing of the packaging for sterilized medical devices, but also the sterilize and precise assembly process. Since the ultimate purpose of a packaging system for medical devices is to provide and maintain the sterile integrity of the product, validating the process in accordance with industry standards is crucial to guaranteeing the final product’s integrity.

Another leading industry depending on the sealing industry to maintain the integrity of it products is food packaging.

This includes not only shelved food packages, but also fish, seafood, bread, and confectionery items. Consumer-centric, the food industry demands (and counts on) all packaging sealer companies to stringently adhere to established industry regulations. Just like with the medical industry, without sealer standards in place and monitored in the food packaging industry, the potential detriments to consumers, businesses, and the environment are high.

Foods need to be packaged, preserved, and shipped in specific ways that adhere specifically to health, safety, andenvironment regulations. In addition, many products need those same food items packaged and presented in such a (sealed) way that they are aesthetically appealing to consumers.

Sealer standards not only keep consumers and users safe from outside irritants, molds, bacteria, and other life-threatening intruders, but also keep businesses competitive, integrity-based, and quality-oriented. Without regulations put in place and monitored to ensure compliance, some business owners would strive to produce the most cost-effective and profit-generating quantity of products with the least amount of concern for quality and product integrity. Sealer standards and industry regulations significantly limit this from occurring. Once a medical company or grocer learns that one or more of their products are tainted (as a result of the packaging being compromised) and has possibly injured or put the health and safety of a consumer at risk, they are going to go directly back to the source of that product’s sealer. A sealer business won’t be competitive (or permitted to continue operating) if industry regulations are not followed.

Consistent quality always overrides quantity.