Equipment steam sterilizer

Steam sterilization validation. All autoclave operations conform to the Master Validation Plan employed at ABC Pharmaceutical Industries. The autoclave has undergone installation qualification, operational qualification, and performance qualification. The autoclave is revalidated on an annual basis. The equipment steam sterilization cycle revalidation data for the autoclave are provided in validated archives. 

Polyarylsulfones offer materials with good thermal-oxidative stability, solvent resistance, creep resistance, and good hydrolytic stability. Their low flammability and smoke evolution encourage their use in aircraft and transportation applications. They hold up to repeated steam sterilization cycles and are used in a wide variety of medical applications such as life support parts, autoclavable tray systems, and surgical and laboratory equipment. Blow-molded products include suction bottles, surgical hollow shapes, and tissue culture bottles. PPS has a number of automotive uses including as an injection-molded fuel line coimector and as part of the fuel filter system. 

Tanks with vent hlters must be designed for pressures of -20 kPa and +100 kPa and must be equipped with a rupture disk. Tanks for hot loop and steam sterilizable line must be designed to withstand steam sterilization (121°C). A steam jacketed sterile vent hlter must be used to avoid condensation in the hlter and the vent hlter housing temperature controlled. The tank for hot storage is steam jacketed and insulated for temperature maintenance. Minimum instrumentation shall include level indication, temperature recording controller, pressure gauge, and pressure relief valve. 

Be constmcted of welded stainless steel (nonrusting grade) equipped for sterilization with steam, except that sanitary stainless steel lines with fittings capable of disassembly may be immediately adjacent to the equipment of valves that must be removed from the lines for servicing and replacement. 

A heat penetration study dehning load cool points is not limited to load conhgurations composed of liquid-hlled vials. The same principles can be applied to process equipment loads (hlters, hoses, etc.) subject to steam sterilization. Penetration thermocouples are positioned at points within the process equipment suspected to be the most difficult for steam heat penetration. Temperature data are obtained from representative maximum and minimum loads in order to establish temperature prohles... 

Component sterilizers steam sterilization process. A steam autoclave is used at ABC Pharmaceutical Industries to sterilize equipment and components used in aseptic processing. The following system description... 

Process and equipment validation certification guideline Hot air sterilization tunnel certification/validation guideline Steam sterilization certification/validation guideline Validation and certification of hot air sterilization tunnel Validation and certification of SIP preparation/mobile vessel Validation/revalidation of sterilization cycles in sterilizer by Kaye validator... 

Perform microbiological challenge studies to determine the degree of process lethality provided by the sterilization cycle. The microorganisms most frequently utilized to challenge steam sterilizer cycles are Bacillus stearothermophilus and ATCC 7953. The Kaye validator equipped with 12 (minimum) thermocouples and biological indicators (10 ) shall be positioned in the detected cool points of the chamber and condenser. After the sterilization cycle is complete, the B.I s are recovered and subjected to microbiological test procedures. 

Formaldehyde and glutaraldehyde are used for disinfection or sterilization of instruments such as fiberoptic endoscopes, respiratory therapy equipment, hemodialyzers, and dental handpieces that cannot withstand exposure to the high temperatures of steam sterilization. They are not corrosive for metal, plastic, or rubber. These agents have a broad spectrum of activity against microorganisms and viruses. They act by alkylation of chemical groups in proteins and nucleic acids. Failures of disinfection or steri... 

Change affects not only methodological aspects of laboratory work but equipment requirements as well. For example, thermal cyclers are a necessity in molecular laboratories today but were unheard of before the advent of PCR. PCR technology has also made it possible to do a good deal of comparative molecular work without the aid of ultracentrifuges or steam sterilizers, items that are expensive but irreplaceable components of a standard molecular genetics laboratory. Clearly, it behooves die researcher... 

When carrying out cell disruption operations it is often necessary to provide cooling of the cell concentrate due to the high pressures developed in the equipment. An additional consequence of high-pressure operation is that cell disruption equipment can generate aerosols which may be undesirable, particularly for biologically hazardous organisms. In these cases, the ability to steam sterilize the equipment is required, for decontamination, and some type of secondary containment may also be required, such as an isolator or a contained area within a facility to which access is controlled. 

Since most chromatographic stages are found toward the end of the production process, and because very few matrices are suitable for steam sterilization, product protection must be ensured by locating the equipment within a clean room environment. Often, the temperature of the process must be controlled, typically at 4°C, and so the entire clean room may be cooled to avoid the need for local process cooling. 

At industrial scale, careful consideration of the materials of construction for the bioseparation equipment is vital to ensure that the product does not become contaminated, by rust, for example, and also to assure long plant life with good reliability to maximize throughput. Materials that were suitable on a laboratory or pilot scale may no longer be appropriate, where the process and mechanical demands on the equipment may be greater. For example, the plant could be located outside where there are greater extremes of temperature in summer and winter, or equipment may need to be steam sterilized in situ rather than being autoclaved. 

Where steam sterilization is required, the equipment must be self-venting and draining so that condensate drains to a single low point where it can be removed, and air which is trapped at high points can be displaced by steam. 

The science that underpins steam sterilization is well known and has been long established. It is the preferred method of sterilization in the pharmaceutical industry it is used for sterilization of aqueous products in a wide variety of presentations, for sterilization of equipment and porous materials required in aseptic manufacture, in microbiology laboratories for sterilizing media and other materials, and for sterilization of massive systems of vessels and pipework [steam-in-place (SIP) systems]. Numerous rules and guidelines have been published on the topic, yet steam sterilization and particularly bio-validation of steam sterilization is still a subject for controversy and debate. 

The performance qualification (PQ) phase of validation follows the development of the sterilization specifications and of the sterilizer parameters which will deliver them. The purpose of PQ in steam sterilization of pharmaceutical products, equipment, laboratory media, and SIP systems is to confirm that the sterilization specification consistently achieves its intended purpose. The process is run using the parameters derived from process development on (usually) three separate occasions and tested for compliance with a variety of predetermined acceptance criteria. As a subset of PQ, the purpose of bio-validation is to confirm that the lethality expected from the process does not significantly deviate from what is expected. Biovalidation is a test of consistency. If the acceptance criteria are not achieved, there may be need for more process development. 

Steam sterilization is widely used as a terminal process for drug products in glass ampules, vials, syringes, and plastic containers. It is also used for sterilizing closures, filters, manufacturing equipment, and cleaning equipment, etc. 

Fig. 1 Sterile dosage form processing equipment useful for clinical supply manufacture in the pilot plant. (A) Vial and ampule washer (Metromatic. Oyster Bay, NY). (B) Steam sterilizer (Amsco Finn-Aqua, Apex, NC). (C) Vial filler (TL Systems Corp., Minneapolis). (D)Lyophilizer (Edwards High Vacuum International, Tonawanda, NY). (E) Vial capper (The West Co., Phoenix-ville, PA).

Dry-heat sterilization is generally a less complicated process than steam sterilization it is, however, relatively slow and requires higher temperatures and/or longer exposure times. This is because of the fact that microbial lethality is lower with dry heat than that for steam at the same temperature. There are various temperatures and periods of treatment for dry heat depending on the pharmacopeia. The U.S. Pharmacopeia (USP) states that the dry-heat sterilization process for containers for sterile pharmaceutical products should be at a temperature of 160-170°C for a period of 2-4 hr. The British Pharmacopeia states that items sterilized by dry heat should be kept at a temperature not less than 160°C for at least 1 hr. For the Pharmacopeia Nordica, the recommendation is 30 min at 180°C. Different materials and sterilization equipment used account for the discrepancies between these pharmacopeias, but there is also a lack of sufficient information concerning dry-heat sterilization. ... 

Steam Sterilization. Cartridge filter systems discussed for cell harvest applications present no difficulties in steam sterilization. They may be sterilized by autoclaving, with vents open (and filtered) for 1 hr. at 121QC. The same units coupled to fermentation equipment may be sterilized in situ for the same time. 

Chamber temperature should be controllable and monitored throughout all cycles. The temperature obtained in a load is a function of the initial product temperature and Its specific heat, the amount of steam injected, and the effectiveness of the insulation or the jacket at preventing heat loss. Temperature during the exposure phase of ethylene oxide sterilization cycles is not controlled by steam injection into the chamber as occurs in thermal sterilization. Loss of temperature may be compensated for by steam Injection into the jacket. The control probe is usually located within the chamber rather than within the jacket, and control of temperature is a good deal less fine than ini steam sterilizers because of the slower response through the jacket. Ethylene oxide sterilizers should be equipped with both jacket and chamber temperature indicators, and with chamber temperature recorders. Sterilizers should be specified with access... 

Equipment where necessary should be properly sterilized before use, preferably by pressurized dry steam. Other methods can be accepted if steam sterilization cannot be used because of the nature of the equipment. It is important not to... 

Steam sterilizer or dry heat sterilizer or other suitable equipment... 

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