PROTOCOL FOR VALIDATION OF DRY HEAT STERILIZER RTM/QC/EQUALITY CONTROL LABORATORY RATLAM

PROTOCOL FOR STERILIZER (DHS)

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TABLE OF CONTENTS DESCRIPTION OBJECTIVE SCOPE RESPONSIBILITIES PROCEDURE CONCLUSION PAGE No.

FORM A FORM B FORM C PHOTOGRAPH

PROTOCOL NUMBER PROTOCOL AUTHORS

PRO/ :

/99

(MANAGER QUALITY CONTROL)

(MANAGER QUALITY ASSURANCE)

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EQUIPMENT QUALIFICATION TEAM (MICROBIOLOGIST)

(OFFICER QUALITY ASSURANCE)

PROTOCOL APPROVED BY (Sr. MANAGER QUALITY ASSURANCE) DATE OF ISSUE : JULY 1999 JULY 2000

DATE OF REVIEW :

1. OBJECTIVE : The documented evidence that the Dry Heat Sterilizer operated within established parameters and performs effectively for sterilization and depyrogenation purpose. 2. SCOPE :

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This protocol will define the responsibilities, procedures, documentation, references, change control & requalification criteria & acceptance criteria to be used in operating the equipment. 3. RESPONSIBILITIES : a. Writing of Protocol i) ii) Officer Microbiology Quality Control Manager Quality Control

b. Approval & Issue of Protocol i) Sr. Manager Quality Assurance

c. Installation Procedure i) ii) Manager Quality Control Officer Quality Control

d. Evaluation of Results i) ii) Officer Quality Control Manager Quality Control

4. PROCEDURE : 4.1 Validation of autoclave is to be perform to verifya) b) Heat penetration in loaded chamber. Sterilization efficiency of process by bacterial spore challenge study.

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Depyrogenation efficiency of process by endotoxin challenge study. 4.2. Load the DHS with glasswares to be sterilized and depyrogenate. 4.3. Select 8-10 thermocouples and distribute them in the chamber inside different articles to be sterilized and depyrogenated. 4.4. Keep the thermocouples inside tubes, bottles and petridishes.
4.5. Keep one strips of biological indicator of Bacillus subtilis var niger inside each of the

article where thermocouple is placed. 4.6. Prepare 8-10 standard endotoxin vials each containing 10,000 Eu/ml. Place the vials inside chamber near each thermocouple probe. 4.7. Close the DHS oven and switch ON the system
4.8. Set the temperature of DHS oven at 200oC and operate the oven as per SOP no

GLP/CQD/05/96/03/RTM.
4.9. Run the cycle for 2 hrs after reaching the temperature at 200C.

4.10. Note down the temperature display on DHS and datalogger or take printout after every 5 minutes. 4.11. Record the observations in form-A. 4.12. After completion of the cycle, wait to cool down. 4.13. Take out the strips and transfer aseptically into 50 ml Nutrient broth / Soyabean casein digest medium under Laminar Air Flow.
4.14. Incubate the tubes at 30C to 35C for not less than 7 days.

4.15. Keep one strip as such in 50 ml Nutrient broth / Soyabean casein digest medium to serve as positive control along with the sterilized strips. 4.16. Observe the tubes daily for any growth and record the observations in form-B. 4.17. Take out endotoxin vials and assay the endotoxin in baked and unbaked vials as per SOP no. GLP/CQD/05/96/54/RTM. 4.18. Record the observations of endotoxin recovery test in form-C. 4.19. Affix the validation status on DHS indicating the date of validation and next validation date.

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4.20. Above test results to be evaluated with comments by Quality Assurance Manager. 4.21. In case of any discrepancy of above results, supplier/manufacturer has be informed through maintenance engineer. After remedical action, equipment shall be requalified again for above test. Performance tests results shall be again evaluated by Quality Control Manager before giving the approval. 5. CHANGE CONTROL & REQUALIFICATION CRITERIA : If any modification or major changes like design change, electronic control panel it shall be requalified through proper change control system. 6. ACCEPTANCE CRITERIA : Performance results meet the acceptance criteria. 7. CONCLUSION : 1. Equipment shall be considered qualified for the performance provided it shall meet the acceptance criteria. 2. Equipment shall be ready for use.

SUMMARY REPORT AND APPROVALS Equipment Serial Number Identification No. Location Purpose : Dry Heat Sterilizer : : RTM/QC/E: QC Department (Microbiology section) : Sterilization and depyrogenation of Articles

PROTOCOL FOR STERILIZER (DHS)

Frequency of Validation

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: Once in a year.

The equipment is released for use/ requalification required..

PERFORMED BY (Q.C. OFFICER) DATE :

APPROVED BY (Q.C. MANAGER) DATE :