Dry Heat Sterilization Process
- Decontaminate, clean, and dry all instruments and other items to be sterilized.
- Wrap the instruments and other items using foil, double-layered cotton, or muslin fabric; put unwrapped instruments and other items on a tray or shelf; or place instruments and other items in a metal, lidded container.
- Because dry-heat sterilization works by raising the temperature of the entire item to the designated temperature, it is not necessary to open or unlock hinged instruments or other items or to disassemble those with sliding or multiple parts. In addition, instruments and other items can be placed in closed containers.
- Place instruments and other items in the oven, and heat to the designated temperature. The oven must have a thermometer or temperature gauge to make sure the designated temperature is reached.
- Use the list here to determine the appropriate amount of time to sterilize instruments and other items for different temperatures.
- Do not begin timing until the oven reaches the desired temperature, and do not open the oven door or add or remove any items.
- The times shown here represent the amount of time that items must be kept at the desired temperature to ensure that sterilization is achieved. Keep in mind that the total cycle time--including heating the oven to the correct temperature, sterilization, and cooling--is usually twice as long as the time noted here.
- Because dry heat can dull sharp instruments and needles, these items should not be sterilized at temperatures higher than 160 degrees C.
- Leave items in the oven to cool before removing. When they are cool, remove items using sterile pickups and use or store immediately.
- Store items properly. Proper storage is as important as the sterilization process itself:
- Wrapped items. Under optimal storage conditions and with minimal handling, properly wrapped items can be considered sterile as long as they remain intact and dry. For optimal storage, place sterile packs in closed cabinets in areas that are not heavily trafficked, have moderate temperature, and are dry or of low humidity. When in doubt about the sterility of a pack, consider it contaminated and desterilize it.
- Unwrapped items. Use unwrapped items immediately after removal from the autoclave or keep them in a covered, sterile container for up to one week.
Chemical Sterilization: Ethylene oxide, ETO sterilizers are widely used in the pharmaceutical industry and health care institutions to sterilize products sensitive to moisture or heat. These high technology sterilizers are potent in killing pathogens and consist of electrical heating jackets and provide excellent steam and temperature distribution in the heating chamber. The heating chamber is generally made of stainless steel and enclosed with aluminum or stainless steel panels. The machines are also equipped with automatic temperature control mechanism. In ETO sterilization bacteria die from the coagulation or de-naturation of the protein constituents.
An effective EtO process can be properly designed for almost every type of medical device and permeable packaging configuration, provided that all variables are assessed through thorough process design and development. Typically, the EtO process can be broken down into four basic phases, each of which needs careful planning to ensure a safe and efficacious process. The four phases are: (1) air removal, (2) steam injection and conditioning dwell, (3) EtO injection and gas dwell, and (4) gas purge and air in-bleed.
Ethylene Oxide (ETO) Sterilization Process
- Pre-sterilization Conditioning: The ETO sterilization process begins with pre-sterilization conditioning which includes sealing and evacuating the chamber and adjusting the temperature and pressure of the chamber.
- Sterilization: This involves adding sterilant and maintains an optimum operating pressure and temperature in the chamber.
- Evacuation and Air Washing: This process involves evacuating the chamber and giving it a number of airs washing to remove any trace of ETO gas.
- Aeration: Finally any residual ETO in the product or material is removed through aeration, which can either be done in the sterilizing chamber or in a specially designed aeration chamber.
Sterilizing Tunnel is mainly used in Pharmaceuticals, Chemical, Petrochemical and food industry.
- Sterilizing tunnel is a tunnel like region, responsible for dry heat sterilization and depyrogenation of containers, vials, bottles, ampoules etc.
- The containers are sent to the sterilizing tunnel through a conveyor belt and sterilized with the help of heated air flow, which is generated by means of a fan and a heater.
- These highly efficient sterilizers make use of laminar air flow to sterilize glass vials/ampoules and bottles.
- The air flow can be controlled by adapting the rpm of the fan during the heating phase.
- In pharmaceutical processes, proper CIP integration is critical to the overall success of the operation.
- Cleaning in Place or CIP systems are widely used in the pharmaceutical and biotechnology industry to clean and decontaminate tanks, reactors, decanting pumps, and transfer lines etc.
- CIP integration starts with the proper selection of the CIP System Skid to deliver the required cleaning parameters to the intended targets.
- The variables of temperature, velocity/pressure, chemical concentration, and exposure time are precisely controlled by the CIP System Skid, which can be configured with many options not only to deliver the specified CIP parameters in a reliable, repeatable and verifiable manner.
- CIP system ensures improved hygiene and sanitize more effectively than manual cleaning.
Pharmaceutical products are produced under strict aseptic conditions, in compliance with existing regulations. Safety is an essential part in pharmaceutical production. Production requires controlled cleaning and/or sterilizing of the production line. The SIP system meets these requirements. This focus on safety ensures that security is maintained for the people and the product. SIP System facilitates a reproducible cleaning process for the dosing system.