What is the importance of maintain In-house isolate and their library in sterile pharmaceuticals?

• Identification of environment isolates very important and mentioned in different guidelines.(USP General chapter 1116, EU GMP, WHO-GMP and PIC/S).
• A lot of microorganisms are found in the air and water of pharmaceutical manufacturing area.
• These organisms some of these may be pathogenic and non pathogenic.
• Pathogenic organisms harmful for the products and humans, these should be addressed  and monitored frequently.
• These environmental Isolates are main source of the product contamination.
• Use full of investigation of source of contamination in pharmaceutical product.
• Every new isolate found  should be investigate and possible source.
• Once In-house isolates are identified, it's important to have a complete information (Library) of the organisms. Likes characteristics, photographs,Type of of identification tests and Identification results, source of possible contamination.
• In-house library should be maintained and updated regularly must be reliable and accurate.
• In-house library could be easily traced and if any previous history out come.
• These In-house isolates presence and using MLT validation, Disinfectant validation and sterility validation and to be prove these organisms also testing the supported to nutrient media.

As per USP

• A successful environmental control program includes an appropriate level of identification of the flora obtained by sampling.
• A knowledge of the flora in controlled environments aids in determining the usual microbial flora anticipated for the facility and in evaluating the effectiveness of the cleaning and sanitization procedures, methods, agents, and recovery methods. 
• The information gathered by an identification program can be useful in the investigation of the source of contamination, especially when recommended detection frequencies are exceeded.
• Identification of isolates from critical and immediately adjacent areas should take precedence over identification of microorganisms from noncritical areas.
•  Identification methods should be verified, and ready-to-use kits should be qualified for their intended purpose.

Chemical Indicators(Autoclave tape) composition

Chemical Indicator is called Process Indicator or Class-1 Indicators or Autoclave tape.

Chemical Composition:

1. Semi-Bleached craft paper
2. Natural Rubber Saturent
3. Natural Rubber adhesive
4. Butylated Urea- Formaldehide resin
5. Acrylate copolymer
6. Lead  carbonate hydroxide
7. Ethyl Alcohol

• Process indicator tapes with lead or without lead available.
• Lead is very poisonous metal, this material is neurotoxic and can cause brain disorders.
• Process indicator tapes are available in the market with different brand names.
• Process indicator tapes which contains lead basically converted in to light colour to dark after processing in sterilization.
• Disposal of these tapes containing lead is very important. These tapes can't be disposed off anywhere because it can cause health risk to living beings.
• These lead containing tapes should be disposed off as hazardous chemical waste by taking precautions.
• But now a days, there is another option available in the market that is class 1 indicator tapes without lead.
• These tapes are very safe to use and doesn't come under the category of hazardous waste.
• Before purchase you can check whether lead free is mentioned on the tape or not, and verify the MSDS also.
• In pharmaceutical companies, class 1 indicator tapes with lead or without lead are commonly used.
• Autoclave tape is also called adhesive tape or process indicator or chemical indicator.
• Autoclave tape Verify the sterilization process.
• Autoclave tape is an adhesive tape used in autoclaving (Heating under high pressure with steam to sterilize) to indicate whether a specific temperature has been reached.
• Autoclave tape works by changing color after exposure to temperature commonly used in sterilization process, typically 121 degree C in a steam autoclave.

Related : Classification of Chemical indicators