Two years of shelf life on sterile moulded glass bottles at PACKSYS
Two years of shelf life on sterile moulded glass bottles at PACKSYS
Sterility of primary packaging is an increasingly important aspect, especially in the pharmaceutical sector. Manufacturers are relying on preservative-free products, but must still be able to guarantee the quality of their products. PACKSYS is the only supplier in this field to offer its customers a two-year guarantee on sterile glass bottles.
Validations of PACKSYS
The sterility of primary packaging is strictly regulated. Our snap-on bottles series amber glass is fully validated (according to DIN ISO EN 11137-1 to -3, DIN ISO EN 11737-1 to -2, DIN EN 11607 and DIN ISO EN 11135:2014) ) and is available gamma-irradiated sterile up to a size of 50 ml. The bottle series was specially developed by PACKSYS for APF pumps (pumps for preservative-free filling). Regular revalidations assure the highest standards. As a result, PACKSYS can guarantee customers of this product range a shelf life of two years.
Full validation is also planned for the plastic version in the current year 2021. In addition to the existing gamma-irradiated product line, this includes the conversion of EO gassed goods to triple packaging as well as transport and packaging validation.
Furthermore, we have expanded our range of sterile packaging solutions in recent years to include various sterile ophthalmic products. For the above mentioned packaging materials we offer validation as standard.
Customer-specific validations
The validation of a sterilization process is a procedure that takes several months and involves a wide variety of steps. As a service, PACKSYS offers validations specifically on customer request. Here, the offer includes various techniques, such as electron beam/e-beam, ETO and gamma sterilization, which are used depending on the product and material. PACKSYS accompanies the entire process of communication, testing, documentation and revalidation. If you are interested or have any questions, please contact Susanne Watzl (susanne.watzl@packsys.de).
Use of preservatives vs. sterile packaging
Preservatives provide a longer shelf life for products. In non-sterile systems, contact with outside air can lead to germination and, in the course of time, to contamination of the contents, which is harmful to health. This process is slowed down by the addition of preservatives. However, these additives can cause allergic reactions. Particularly in the case of longer treatment phases, one would like to reduce the long-term exposure for the user. The solution is a fully sterile product that prevents germ contamination in the first place.
Request sterile products from PACKSYS: info@packsys.de