Steam Operated Autoclave use in Pharmaceuticals SOP

Standard Operating Procedure of Steam Operated Autoclave use in Pharmaceuticals is describe in this post.

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1 PURPOSE

1.1 It is established to provide a procedure for proper sterilization of (Rubber Stopper, Uniform, Parts of machine, filled glass vials and ampoules) to meet the cGMP requirements

2 SCOPE

2.1 It is applicable in sterile Injection Section.

3 RESPONSIBILITIES / AUTHORITIES

3.1 Production Supervisor 

3.2 Machine Operator

3.3 Quality Assurance inspector

3.4 Section In charge

4 REFERENCES

5 DEFINITIONS

5.1 List of Technical Definition 

6 PROCEDURE

6.1 CLEANING:

6.1.1 Wipe with moist cloth internally and externally autoclave.

6.1.2 Remove broken glass pieces from the autoclave.

6.1.3 Check and clean the steam and air showers. 

6.1.4 The Machine Operator/Line In charge/Section In charge/Sub-Section In charge will maintain Machinery/Equipment Cleaning Logbook.

6.2 STARTUP & OPERATION:

6.2.1 First of all load the autoclave with trays of material and equipment to be sterilized

6.2.2 Check the level of steam pressure from stem pressure gauge and maintain it at the specified level.

6.2.3 Check that compressed air valve, steam in valve and steam out valve are working proper. 

6.2.4 Open the steam valve and exhaust steam to clean steam line from any blockage of broken glass and condensate

6.2.5 Close the door of the autoclave and make it airtight. 

6.2.6 Paste Autoclave indicator on different trays in different locations of S/S trays. 

6.2.7 Close the door of autoclave and tighten its nuts. 

6.2.8 Open steam and compressed air valve 

6.2.9 Gradually temperature and pressure rises. Check the temperature and pressure gauges at regular interval.

6.2.10 Make adjustment of steam in valve so that temperature gauge show temperature at 115OC -118 OC and pressure gauge show 10 lb. and same readings on digital control screen and all its probes indicating uniform distribution of steam in all areas.

6.2.11 Start time and hold material for 30 mints or according to required time.

6.2.12 After completion of sterilization cycle close steam in valve and open steam out valve

6.2.13 When pressure drop to zero than open air shower to decrease temperature for 20 minutes.

6.2.14 Open the autoclave door and observe autoclave indicator.

6.2.15 Unload the sterilized trays in sterile area.

6.2.16

7 PRECAUTIONS

7.1 Never open the autoclave chamber door until the pressure is zero.

7.2 Always ensure that the steam pressure safety valve is operative.

7.3 Always wear protective gear when working on the autoclave.

8 DOCUMENTS / RECORDS

8.1 Machinery Equipment Cleaning Log

8.2 Equipment/Utensil Cleaning Analytical Report

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