TM Media Biological indicators India
FDA and ISO regulated biological indicators are used to monitor Sterilizers established in health care facilities, thus preventing infection and cross-contamination. With the increased usage and growing population, the necessity for Sterilization has grown manifold. Effective infection control is the essential requirement to prevent cross contamination at all levels. There are two infection control methods which are most commonly used worldwide - Disinfection and Sterilization. Sterilization is considered as the best method over Disinfection because Disinfection reduces microbial contamination but is less lethal to pathogenic organisms as compared to Sterilization. Disinfection does not remove all vegetative spores, but on the other hand, Sterilization ensures to remove all forms of microorganisms including viruses, bacteria, fungi and spores.
 
The efficacy of a Sterilization procedure is monitored by various methods with the help of Chemical Indicators and Biological Indicators. Biological Indicators or Spore Tests are the most accepted means of monitoring Sterilization because they assess the Sterilization process directly by killing highly resistant microorganisms (e.g. Geobacillus or Bacillus species). Spore Test is recommended to do weekly. Thus, to check Sterility on daily basis chemical monitoring should also be done.
Chemical Indicators only ensure that instruments have been exposed to sterilization cycle by change in their colour, but it cannot be verified that complete Sterilization has been achieved, and all vegetative spores have been destroyed. They help to detect procedural errors (e.g. overloaded sterilizer, incorrect packaging) and equipment malfunctions. Chemical monitoring if possible should be done for every sterilizer batch.
Earlier and even today Sterilization validation is often neglected during medical/ hospital and laboratory sterilization. Instruments, Packs, Media and Glassware are autoclaved and the cycle is begun and it is assumed that the sterilization load is sterile. This can be extremely dangerous and even fatal in some surgical applications.
To ensure an actual sterility, TM Media has come up with Biological Indicators and Chemical Indicators with which the precise sterility results are possible. Products complies with USP, ISO guidelines and US Food and Drug Administration’s quality system regulations. In conventional microbiological culture, the effectiveness of sterilization process is studied by spore growth or colour change.
Biological Indicators and Chemical Indicators have been in use for several decades and are used widely especially in hospitals, food processing, dentist offices, pharmaceutical, medical device manufacturing, ambulatory surgical centres, even in tattoo parlours in some part of the counties and anywhere else where validation and verification of an adequate sterilization cycle is required.
Indicators come in different shapes, sizes and configuration as following:

BIOLOGICAL INDICATORS
The need of effective Sterilization method and its monitoring is necessary. Biological Indicators are a set of specific microorganisms with high resistance towards particular Sterilization methods. Their processes include Steam Autoclave, Dry Heat Sterilizer, Ethylene Oxide Sterilizer.
Generally, the following spores are used for the Sterilization methods listed below in Table 1.
 
STERILIZATION PROCESS
SPORE (INDICATOR ORGANISMS)
VIABLE SPORE POPULATION
Table 1: Spores used in sterilization process
Steam
Geobacillus Sterothermophilus
105 and 106
Gas and Dry Heat
Bacillus atrophaeus
(formerly Bacillus subtilis)
105
Radiation
Bacillus pumilus
105
We offer following types of Biological Indicators:
  A) SPORE STRIPS: Spore strips consist of spores impregnated on chromatography paper strips, individually placed in envelopes. Number of spores present per strip is 105 or 106. These are widely used for a variety of sterilization processes since many years.
 
B) SPORE AMPOULES: These are self-contained Biological Indicators used to validate or monitor Steam Sterilization. It consists of a sealed ampule containing Geobacillus stearothermophilus spores, suspended in a modified Soybean Casein Digest Broth. A pH indicator of Bromo Cresol Purple has been added to assist in detecting spore growth.  These indicators have become much more popular as they are more user friendly and offer reduced incubation period.

Fig: -: Purple Colour (Complete Sterilization)
        +: Yellow Colour (Incomplete Sterilization)

CHEMICAL INDICATORS
Chemical Indicators use sensitive chemicals to assess critical variables (e.g., time, temperature, or steam saturation) during a Sterilization cycle. They are applied either to the outside or placed on the inside of each instrument unit (e.g., packs, peel pouches, containers, etc.). We offer following range of Chemical Indicator as following:
1. SELF ADHESIVE STERILIZATION INDICATORS: These tapes have good adhesion to woven and non-woven fabrics. It offers the complete colour changing line of Chemical Indicators to meet industry standards.  Strips change colour with certain Sterilization process. These are easy-to-use and are used for sealing packages before Steam or Ethylene Oxide (EO) Sterilization.
STERILIZATION PROCESS
PRODUCT DESCRIPTION
Table 2: List of Self Adhesive Sterilization Indicators
Radiation
Circular Indicator with Text (12.7 mm)
Ethylene Oxide
Circular Indicator with Text (12.7 mm)
Dry Heat
Plain Indicator Circular (12.7mm) (Temp.: ≤250˚C)
Dry Heat
Plain Indicator Circular (12.7mm) (Temp.: ≤180˚C)
2. STERILIZATION INDICATORS FOR STEAM: During processing, the cycle must remove or displace the air from the barrier material and replace it with steam through the pack. A uniform colour change indicates adequate steam penetration. The colour transition allows end users to easily identify goods which have been exposed in a steam autoclave. The indicators are designed for use in pre-vacuum Steam Sterilizers operating at 121°C and up to 135°C.
The test itself provides repeatable, reliable, accurate results. The test is non-reversible which ensures documentation of the verification safe and easy.
 
STERILIZATION PROCESS
PRODUCT DISCRIPTION
Table 3: List of Sterilization Indicators for Steam
Steam sterilization
Bowie and Dick Test pack
Steam sterilization
Plain Indicator Circular (12.7mm)
3. CHEMICAL INDICATOR TAPE: The Chemical Indicators are used to distinguish between processed and unprocessed items placed within sterilization wraps, containers, trays or pouches. They indicate through a visible colour change, when the item has been exposed to a Sterilization process.
 
STERILIZATION PROCESS
PRODUCT DISCRIPTION
Table 4: List of chemical Indicator Tape
Steam sterilization
18mm x 55mm
Ethylene Oxide
18mm x 55mm
4 CHEMICAL INDICATOR TEST STRIP: Indicator strips must be placed in each pack of each sterilizer load: Strips changes the colour on correct integration of temperature, time and humidity and concentration of sterilizing agent.
 
STERILIZATION PROCESS
PRODUCT DISCRIPTION
Table 5: List of chemical Indicator Test Strip
Steam sterilization
112mm x 20mm
Dry Heat
112mm x 20mm
For accurate and good results, precautions are mandatory such as all Sterility tests should be performed in a clean dust free transfer area, preferably under positive air pressure using rigid aseptic technique throughout the Test procedure. Using Sterile scissors, cut open one end of the envelope. Also storage conditions should be maintained.
 
Click below to view complete range of Biological and Chemical Indicators

BIOLOGICAL INDICATORS

CHEMICAL INDICATORS

 

Share