sir, please give some information about validation of autoclave by using Biological indicator

With regards

Dear Sandeep

I give the brief Idea of Autoclave Validation.

1. Steam Quality Test
a. Dryness Test
b. Non Condensable Gas Test
c. Super Heat Test

2. Leak Test Of Chamber
3. Bowie Dick Test
4. Empty Chamber Heat Distribution Test Using The Thermo Sensor.
5. Heat Distribution Study with Load ( As Per Load Pattern – Each Load Having 3 Runs)
Using Thermo Sensor.
6. Heat Penetration Study with Load ( As Per Load Pattern – Each Load Having 3 Runs)
Using Thermo Sensor and Biological Indicator.

If you have any Query Reply Or call me

For decades, steam sterilization (autoclaving) has been an integral part in the manufacturing, cleanroom, and laboratory processes for the medical device, pharmaceutical, biologics, and human tissue/HCTP industries. It has been a common industry practice to validate steam sterilizers using the published guideline ISO 11134 Sterilization of health care products — Requirements for validation and routine control - Industrial moist heat sterilization, issued in 1994. In late 2006, AAMI released the document intended to supersede 11134, with ANSI/AAMI/ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.


The 17665 document makes it clear in numerous locations that the user’s quality system must adhere to ISO 13485:2003 Medical devices — Quality management system — Requirements for regulatory purposes.So if a user wishes to claim full compliance with the new 17665 steam standard, then their quality system must also be in compliance with ISO 13485, including items such as preventive/periodic maintenance and regular calibration for the sterilizer, documentation, change control, purchasing, etc. When compared with the previous steam document, the new 17665 also has more information on product and process characterization, sterilizing agent characterization, installation qualification/IQ, and operational qualification/OQ. The new document also states more clearly that a fully compliant validation is not just a series of successful halfcycles,but is the full complement of successful IQ, OQ, and PQ.

Sterilization agent characterization will be simple for most users — moist heat/steam at 121 or 132 °C, and cycle selection (gravity, prevacuum, etc.). Process and equipment characterization means defining and documenting items like the sterilizer cycle parameters, products (or product families) to be sterilized, load configurations and limits, placement of biological indicators or chemical indicators (BIs/CIs), process tolerances, and equipment identification. Much of this type of information would be recorded in well-written validation protocols or validation final reports. Biological indicators often use spores of the bacterial species Geobacillus stearothermophilus at a titer of greater than 106per BI, although other species or titers are sometimes used.

The new 17665 document also has more information on IQ and OQ. It defines IQ as “obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification.” Autoclave installations commonly document items such as the sterilizer identification numbers, location, line voltage and amperage, water supply piping and pressure limits, steam line requirements, filtration, chamber size, structure and support, piping materials, software certification, manuals, drawings and documentation, and calibrations (temperature, pressure, and timer). The sterilizer must be installed in such a manner to facilitate any necessary maintenance, repair, adjustment, cleaning, and calibration.

OQ is defined as “obtaining and documenting evidence that the installed equipment operates within predetermined limits when used in accordance with its operational procedures.” Autoclave OQs commonly test or verify items such as cycle operation and programming instructions, safety and alarm testing, error reporting, empty chamber temperature profiling and chamber temperature limits/specifications, air removal testing, leak testing, temperature control anomalies, full cycle full-load temperature profiles (if proposed full cycle exposure time is known), and determination of any hot or cold spots within the chamber.

There are many other activities or decisions to be made prior to or during the IQ/OQ, that are not necessarily detailed in either standard. Items such as:

•Obtaining calibrated temperature recording devices or thermocouples
•Ordering supplies such as BIs, CIs, Bowie-Dick test packs, packaging materials, etc. and noting if adequate laboratory facilities are available
•Determining worst-case validation load and worst-case test product or PCD. The protocol or final report should contain a written rationale describing how the loads and product(s) were selected
•Selecting cycle type: 121 or 132 °C, gravity or prevacuum cycle, etc.; and determining if drying time needs to be qualified
•Is product bioburden testing necessary?
•Is product re-sterilization to be allowed and what are the requirements for re-sterilization?
•Is product stability or shelf life testing necessary for the user’s products?
•Does packaging testing or packaging validation need to be included with the protocol?

An example of validation protocol and final report sections would be:

•Title page with approval signatures
•Purpose, background information, or general goal(s) of validation
•Scope with more specifics about methods, cycles, facility, SAL, products and load, exclusions, etc.
•References with published standards and company SOPs
•Equipment, supplies, validation loads, BIs, etc.
•Rationale for selection of products, load, cycles, PCDs, etc.
•Procedure or methods (more details on this below)
•Acceptance criteria which list the pass/fail requirements
•Deviation report which lists any unexpected results, with potential effects on the validation, along with accept/reject rationale
•Results and conclusions which assign a pass/fail decision to each acceptance criteria, summarize study, and include any requirements for revalidation
•Attachment which lists any data sheets, diagrams, certificates, temperature records, etc., for inclusion with final report
•Approvals section for final report.


Hello, could you explain me the difference?

Information provided by rajeev haritas is short but it’s easy to understood…I am sharing small data related to this topic,which I collected from one article as
autoclaving is conducted by supplying dry, saturated steam under pressure to an autoclave. The energy from the condensation of steam on the items in the sterilizer will kill the present microorganisms by irreversible damage of cell components.
The effectiveness of a moist heat sterilization process increases considerably when air is removed before adding steam to the chamber. Obtaining a vacuum can be difficult, resulting in limited capability of the steam to penetrate into cavities of instruments etc. The use of biological indicators during autoclave validation / Qualification is therefore recommended for monitoring allowing the conditions at different points in the sterilized goods to be assessed.

did you mean “no load” on one of those?

no this correct, Heat distribution and heat penetration are two different kind of measurments and tests.