Steam Sterilization, especially the type that is produced through an autoclave air-over-pressure sterilization system, is widely used for terminal and medical device sterilization. However, the CDC and FDA are constantly modifying and perfecting the regulations attached to clinical trials and pharmaceutical manufacturing, which means the steam sterilization process itself is always under scrutiny.
In fact, in chapter 5.1.1 of the European Pharmacopeia (EP), protocols and guidelines surrounding steam sterilization are under review. The publication is entitled, “Methods of Preparation of Sterile Products,” and is located within EP edition 26.4.
In the publication, the European Pharmacopeia reveals that they have added more contemporary concepts and best practices for validating steam sterilization. Additionally, they have widely expanded the descriptions of equipment that are suitable for dry heat and steam sterilization.
Traditionally, drug manufacturers utilized reprocessed stainless-steel containers for the purpose of biofermentation and cultivation of drug products. Currently, the pharmaceutical industry is making a movement towards using single-use containers. With the creation of these single-use containers will also come the necessity for proper, appropriate processing and delivery of the containers to and from medical-related industries. This is just one way Gibraltar Laboratories, Inc.’s CRO will serve their clientele—through delivering these single-use containers, sterilized carefully.
With these changes coming to the pharmaceutical development, research and manufacturing industries, it’s important to know both the advantages and disadvantages to using steam sterilization. Steam sterilization is a process utilizing pressurized, saturated steam for a certain pre-determined amount of time at a carefully selected temperature in order to achieve sterilization.
Steam sterilization holds many advantages in the pharmaceutical and medical fields. First, steam is non-toxic to patients, staff and the planet. The sterilization cycles are easily controlled and monitored. Additionally, steam is rapidly microbicidal and the sterilization process will penetrate most medical packing and device lumens.
Steam sterilization should be avoided for heat-sensitive instruments, and repeated exposure to steam may damage microsurgical instruments. To assess the affect of multiple sterilizations on a product, Gibraltar performes Life Cycle testing. Multiple cleaning and sterilization cycles are performed on the device. Additionally, the products become hot which can burn unwary users, and the excess water can cause rusting in some situations.
Gibraltar Laboratories, Inc. will take into account all of the advantages, disadvantages and risk factors as our CRO’s skilled staff walk clientele through the steam-sterilization and single-use container manufacturing processes.
With these changes coming in Europe and America, it’s important to find a CRO that stays with the times and develops new strategies and products that accommodate the constant advances in technology and changes in practices by government organizations.
That is just one part of our mission as a top-notch CRO.