Hold Time Study for Cleaned FBD Bags

TABLE OF CONTENTS

1. Table of Contents
2. Protocol Pre-Approval
3. Overview
4. Validation Procedure
5. Training Needs
6. Equipment Hold Time Study Data Sheet for Microbial Analysis
7. Deviations
8. Incidence / Failure
9. Corrective and Preventive Action
10. Summary and Conclusion
11. Protocol Post Approval

1.   PROTOCOL PRE-APPROVAL:

Protocol has been prepared by, reviewed by and approved for implementation by the undersigned.

    

2.   OVERVIEW

2.1  Objective:

• To study Hold time duration of cleaned FBD Bags to decide time duration for which it can be valid for further processing.

2.2  Purpose:

• This validation exercises the study of Hold time duration of cleaned FBD Bags to establish documentary evidence of time period for which it can be hold or valid for further processing.

ALSO READ: SOP for Hold Time Study in Pharmaceuticals

2.3  Responsibility:

3.   VALIDATION PROCEDURE

3.1  Criteria for Selection of FBD Bags for Hold Time Studies:

• FBD bags are selected on the basis of biological and non-biological products. (For example) Following two products dedicated FBD bags are used for Hold time studies.

1. Azithromycin (Biological Product)
2. Losartan Potassium (Non biological Product)

 

3.2  Sampling Procedure:

• The Sample shall be collected using sterile swabs for microbial contamination testing using a surface area of 100 sq.cm2.
• Take 10 ml of 0.9% w/v Saline and sterilize it by means of autoclaving & transfer it in sterilized swab tube aseptically.
• Remove the swab from the diluent by squeezing the excess diluent solution in to the swab tube and sample the 100cm2 area by the method described below. Hold the stem of the swab and wipe the test surface by 10 firm horizontal strokes and then 10 firm vertical strokes as illustrated in the figure below.

• Place back the swab in to the swab tube containing 10ml of the solvent and transfer the tubes to microbiology section.
• Sterile cotton swab with polypropylene stick, Size 75 x12 mm diameter individually packed, Make – Hi Media.

3.3  Frequency of Sampling:

• Sample shall be collected at Initial stage, Third day, Fifth day, Seventh day, Tenth day & Fifteenth day of cleaning for total microbial count and pathogens testing.

3.4  Parameters for Testing:

• Only microbial testing (MLT) shall be performed for the hold time studies as bags are dedicated for each product.

• Testing shall be performed as per SOP for Microbial Limit Test (SOP No.)

ALSO READ: Why Three Batches are Taken for Validation?

3.5  Acceptance Criteria:

• Total microbial count shall not be more than 100cfu/ cm2 and shall be free from pathogens.

4.   SUMMARY AND CONCLUSION

• Record the data in respective data sheets and after evaluation of the results, a summary and conclusion shall be made by clearly stating the cleaned Finger bags hold time.

5.   TRAINING NEEDS

Name of the Trainer:

Venue:

Date:

Sr. No.	NAME OF TRAINEE	DEPARTMENT	SIGNATURE
1
2
3
4
5
6
7
8
9
10

Signature of Trainer:

6.   FINGER BAGS HOLD TIME STUDY DATA SHEET FOR MICROBIAL ANALYSIS

      Product:  (Biological Product)          FBD Finger bag I.D.:

REMARKS:__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________


 Done By                                                  Checked By

Product:  (Non Biological Product)         FBD Finger bag I.D.:

REMARKS:__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________


 Done By                                                  Checked By

7.   DEVIATIONS OBSERVED:

_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

8.   INCIDENCE/FAILURE:

_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

9.   CORRECTIVE ACTION & PREVENTIVE ACTION:

_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

10.   SUMMARY AND CONCLUSION:

_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

11. PROTOCOL CUM REPORT POST – APPROVAL

ALSO READ: SOP for Hold Time Study for Intermediates