Pharmaceutical Sterilizers

Sterilizers are special equipments used to make a product free from live bacteria or other microorganisms. The sterilizer process is used to kill all microbes.
Sterilization can be achieved through application of heat, chemicals, irradiation, or filtration. There are several kinds of sterilization equipment using different
technology and processes, according to the application.

 Steam Sterilizer

 Dry Heat Sterilizer

 ETO Sterilizer

 Sterilizing Tunnel

 CIP System

 SIP System

Steam Sterilizer

Steam sterilizers provide a cost-effective solution to sterilize medical waste, infectious waste and other material. Steam Sterilizer
Equipment not only helps to eliminate the problem of environmental pollution by doing away with methods like incineration but
also helps to minimize and eliminate the expense of disposing off untreated medical waste. This sterilizing equipment sterilizes the
waste by exposing it to steam under high pressure, thereby making it free of any contaminants. Manufacturers can design
customized sterilizers to suit the needs of individual clients and the waste treating capacity varies depending on the size of the
plant.

Steam sterilizer is mainly used in Pharmaceutical, Chemical, Food & Beverages and Medical and other Waste Processing Centers.
Steam Sterilization is a widely-used method for heat sterilization is the autoclave. Autoclaves commonly use steam heated to
121°C (250°F), at 103 kPa (15 psi) above atmospheric pressure. Proper autoclave treatment will inactivate all fungi, bacteria,
viruses and also bacterial spores, which can be quite resistant. It will not necessarily eliminate all proteinaceous infectious particles (prions).

Dry Heat Sterilizer

 Dry heat can be used to sterilize items, but as the heat takes much longer to be transferred to the organism, both the time
and the temperature must usually be increased, unless forced ventilation of the hot air is used.
 The standard setting for a hot air oven is at least two hours at 160°C (320°F). A rapid method heats air to 190°C (374°F)
for 6 minutes for unwrapped objects and 12 minutes for wrapped objects [1] [2].
 Dry heat has the advantage that it can be used on powders and other heat-stable items that are adversely affected by
steam.

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.

ETO Sterilizer

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

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.

CIP System
 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.

SIP System

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.