Vacuum sealers for sterile packs
Sterile packaging is an indispensable requirement of the medical industry. Manufacturers of medical devices use packaging to keep their products sterile and protected from damage, right from the packaging stage through transportation, storage and distribution, up to the time that the product is opened for end usage. Vacuum sealers, which cater to this requirement, play a principle role in the whole chain.
The sterile packaging may require adhering to some unique and specific application-related needs. For effective vacuum sealing of sterile packs, it is imperative to consider the integrity of the seal, which the vacuum-sealing machine creates. It is crucial that the vacuum sealer is able to repeatedly deliver strong seals of consistent strength.
Manufacturers of all equipment/material for sterile vacuum packaging are required to maintain and operate within the quality guidelines of the FDA, which lays down GMP (Good Manufacturing Practices) specially meant for dictating requirements for medical device manufacturers. An ISO 9000 certification signifies a company with the required high standards and is an indication that it adheres to GMP. Companies engaged in activities in dealing with materials and equipment for sterile conditions should have at their disposal clean room facilities, to allow sterile packaging in a controlled environment. These would include vacuum forming, bag/pouch sealing, die cutting and laminating.
Reputed manufacturers of vacuum sealers for sterile packs have state of the art laboratories that allow them to evaluate the pouches and bags sealed by their machines, in order to understand better the total value of the seals produced by their machines. The process includes scrutinizing sterile packs by putting them through multiple 'seal strength challenge' tests. There can be a variety of such tests performed in the whole testing cycle. For example, peel analysis, burst testing and dye penetration, which need to be done with precise resolution. The data that is collected during such robust seal integrity studies are extrapolated through computer interface systems, which allow comprehensive real time data logging with suitable equipment. The data is collected up to twenty times per second and the tests are conducted as many as fifty times per year.
While testing, the pouches/bags used for the sterile vacuum packaging are sealed and subjected to an ANSI (American National Standards Institute) seal strength test. The results are studied in order to optimize the vacuum sealer settings in relation to the mil (thousandth of an inch) thickness and substrate of the pouch. Then strips of the package are cut and fitted to a peel fixture and the seal is pulled apart @ ten inches per minute and the whole session is computer captured.