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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
61 & 62 Hootagalli Ind. Area Mysore 571186 Terpinol B.P 9.0%v/v Germicidal
UnilonBK 3 Unilab chemicals & pharmaceuticals pvt ltd, W-32, MIDC Benzalkonium Chloride 2.5% Antiseptic B
Phase II sagaon, Dombivili (E) 421204. solution IP 3% v/v
Savlon Johnson & Johnson Chlorohexidine gluconate 5.0% Antiseptic C
solution IP 1.5% v/v
VPO – Bhatoli kalan, Nalagarh Tahsil, solan, Distt. Baddi,
(HP) Cetrimide IP 1.5% w/v
Procedure:
Group
Disinfectant solution % Concentration
A Dettol 2.5
B Unilon BK 3 2.5
C Savlon 5.0
C) Method:
D) Control:
Acceptance Criteria:
% efficiency:
Efficiency = ------------------------------------------------
Initial TMC
Action Plan
Alert Limit:
Action Limit:
Date:
Annexure – I
Area:
Manufacturer of Disinfectant:
Before ---- 1
cleaning
2
After 0 Hour 1
cleaning
2
After 1 Hour 1
cleaning
2
After 2 Hour 1
cleaning
2
After 3 Hour 1
cleaning
2
After 4 Hour 1
cleaning
2
After 5 Hour 1
cleaning
2
After 6 Hour 1
cleaning
2
Positive control
Negative control
Observed by:
Initial TMC
1. For Time ( ).
2. For Time ( ).
3. For Time ( ).
4. For Time ( ).
5. For Time ( ).
6. For Time ( ).
7. For Time ( ).
Remarks:
Frequency:
Carry out the validation whenever new disinfectant solution shall introduce for cleaning.
Acceptance Criteria:
No growth should appear on the recommended concentration.