Disinfectant Validation Protocol : Pharmaceutical Guidelines

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Disinfectant Validation Protocol

Validation protocol for procedure for validation of diluted disinfectants used in pharmaceutical manufacturing area for cleaning.
Objective:
The Objective of this validation protocol is to study the effect of disinfectant used for cleaning/sanitization purpose in manufacturing area by contact plate method.
Scope:
This protocol is applicable to the disinfectants used for cleaning/sanitization in the manufacturing area.
Responsibility:
Officer Microbiology: Preparation of protocol
Officer QA: Protocol Review
Asst. Manager QC: Protocol review & Verification
AGM QA/QC: Protocol approval

Disinfectant Details
Name of  Disinfectant
Manufacturer
Active Ingredient
Used Dilution
Category
Group
Dettol
Reckitt Benckiser (I) Ltd.
61 & 62 Hootagalli Ind. Area Mysore 571186
Chloroxylenol IP 4.8% w/v
Terpinol B.P 9.0%v/v
Alcohol absolute (denatured) 13% v/v
2.5%
Antiseptic
Germicidal
A
UnilonBK 3
Unilab chemicals & pharmaceuticals pvt ltd, W-32, MIDC Phase II sagaon, Dombivili (E) 421204.
Benzalkonium Chloride solution IP 3% v/v
2.5%
Antiseptic
B
Savlon
Johnson & Johnson
VPO – Bhatoli kalan, Nalagarh Tahsil, solan, Distt. Baddi, (HP)
Chlorohexidine gluconate solution IP 1.5% v/v
Cetrimide IP 1.5% w/v
5.0%
Antiseptic
C

Procedure:
A) Preparation of solutions of disinfectants
1) Dettol : Prepare 1.5,2.0 & 2.5 % solutions in water
2) Savlon : Prepare 2.0,3.5 & 5.0 % solutions in water
3) Unilon BK 3 : Prepare 1.0,2.0 & 2.5 % solutions in water

B) Cleaning and sampling:
1. Pre-incubated contact plate.
2. The disinfectant solution as per planned schedule in a group as follows.
Group
     Disinfectant solution
     % Concentration
A
Dettol
2.5
B
Unilon BK 3
2.5
C
Savlon
5.0
C) Method:
Contact Plate Sampling:
1. Select the area in manufacturing for validation purpose. Take contact plate before cleaning then prepare the disinfectant solution in group A as per the SOP. Clean and sanitize the area as per the SOP. Take contact plates after cleaning as follow.
Procedure for contact plate:
1. Select the disinfectant solution in group A.
2. Use contact plates for bacterial, yeast & mold count.
3. Open the lid of the plate and gently touch to the surface of the disinfected area.
4. Press the plate slightly for proper contact with the surface, and then close the plate.
5. Take contact immediately after cleaning (drying) i.e. zero hour contact time and then take contact plate after 1 hour, 2 hour, 3 hour, 4 hours, 5 hour and 6 hour.
6. Use two contact plates per sampling i.e. before cleaning, 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour and 6 hour.
7. Bring the contact plates to microbiology section and incubate the plates at 30 – 35 ° C for 5 days for bacterial, yeast & mold count.
8. Carry out the same procedure for a disinfectant solution in group B and C in the particular area, as mentioned above
9. Carry out the study once in the shift and take contact plate before cleaning and after cleaning as per the point No. 5 of Procedure for Contact plate,. Compile the results and prepare the summary report.

D) Control:
Keep control for study as follow.
Positive Control:
1. Contact plates are not exposed to disinfectant.
2. Keep positive control plate by streaking suspension of test organisms Bacillus subtilis ATCC6633 and Candida albicans ATCC10231 on contact plate. Incubate the plates at temperature 30 – 35° C for 5 days.
Negative Control:
Negative control contact plates are directly exposed to disinfectant and not streak by any test organisms. Incubate the plates at 30 – 35° C for 5 days for bacterial count and yeast & mold count
Blank Control:
Blank contact plates are not exposed to disinfectant and not streak by any test organisms. Incubate the plates at 30 – 35° C for 5 days for yeast & mold count.
Acceptance Criteria:
Total viable aerobic count:
Alert limit : 20 cfu / 25 cm2
Action limit : 40 cfu / 25 cm2
% efficiency:
Calculate the efficiency of each disinfectants solution as:
                   (Initial TMC – TMC after cleaning) X 100
Efficiency =       ------------------------------------------------
                                         Initial TMC

Total Microbiological count = Average TBC+ Average TFC
Action Plan
Alert Limit:
  1. Check the disinfectant solution preparation procedure.
  2. Check measuring cylinder used for solution preparation.
  3. Cleaning shall monitor very seriously.
  4. Check Manufacturing & Expiry of the solution.
Action Limit:
  1. Revalidate the disinfectant solution.
  2. List down all the accessories used in disinfectant solution preparation and check the status of same.
  3. Calibration status.
  4. Concentrated Solution preparation drum.
  5. Batch No. of disinfectant solution.
  6. Person who prepare the solution.
  7. Accessories used for cleaning purpose.
Training Needs
Name of the Trainer:
Venue:
Date:
Sr.No
Name of Trainee
Department
Signature
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Signature of Trainer:


Annexure – I 
Quality Control Department – Microbiology section
Disinfectant Testing Report
Name of Disinfectant:                          Date of Testing:
B.No. of disinfectant:                           Date of reporting:
Sampling method Used:                       Incubator used:
Media Used:                                        Incubation Temperature:
Batch No. of Media:                             Incubation period:
Area:                                                  
Manufacturer of Disinfectant:             
Conc. Of Disinfectant
Sampling
Plan
Time of sampling
Plate No.
No. of CFU / Plate
After 24 hours
After 48 hours
After 72 hours
After 96 hours
After 120 hours
Average CFU/plate

Before cleaning
----
1






2





After cleaning
0 Hour
1






2





After cleaning
1 Hour
1






2





After cleaning
2 Hour
   1






2





After cleaning
3 Hour
1






2





After cleaning
4 Hour
1






2





After cleaning
5 Hour
1






2





After cleaning
6 Hour
1






2





Positive control






Negative control






Observed by:







                                        (Initial TMC – TMC after cleaning) X 100
  Efficiency% (Conc.)   =    ------------------------------------------------
                                                        Initial TMC

1.   For Time (_______).
2.   For Time (_______).
3.   For Time (_______).
4.   For Time (_______).
5.   For Time (_______).
6.   For Time (_______).
7.   For Time (_______).


Remarks:


Compiled By:                                      Checked By:                              Approved By:

Frequency:
Carry out the validation whenever new disinfectant solution shall introduce for cleaning.
Acceptance Criteria:
No growth should appear on the recommended concentration.
Summary & Conclusion:
Comments as per report compilation
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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