Lactonova Nutripharm Pvt Ltd PROTOCOL No.

Quality Assurance Department CVP-LNP-XXX

xxxxxxxx Manufacturing Equipment Cleaning
Page 1 of 5
Validation Protocol

Protocol Approval

Name Department / Designation Signature/Date

Prepared by

Reviewed by

Approved by

Kishore Gondrala QA Manager

 Lactonova Nutripharm Pvt Ltd PROTOCOL No.
Quality Assurance Department CVP-LNP-XXX
xxxxxxxx Manufacturing Equipment Cleaning
Page 2 of 5
Validation Protocol

Table of Contents

S. Page
Content
No No
01 OBJECTIVE 03
02 SCOPE 03
03 CLEANING VALIDATION APPROACH 03
04 CLEANING VALIDATION STRATEGY 03
05 PRODUCT DESCRIPTION 03
06 EQUIPMENT DESCRIPTION 03
07 RESPONSIBILITIES 04
08 CLEANING PROCEDURE 04
09 DESCRIPTION OF SAMPLING PROCEDURE 04
10 TEST FUNCTION AND ACCEPTANCE CRITERIA 05
11 HOLD TIME OF DIRTY EQUIPMENT (BEFORE CLEANING) 05
12 CLEANED EQUIPMENT HOLD TIME 05
13 ANNEXURE 05
 Lactonova Nutripharm Pvt Ltd PROTOCOL No.
Quality Assurance Department CVP-LNP-XXX
xxxxxxxx Manufacturing Equipment Cleaning
Page 3 of 5
Validation Protocol

1.0 OBJECTIVE

The objective is to demonstrate that the cleaning procedures can successfully and consistently reduce
the level of residues from product manufacturing equipments after manufacturing process, to prevent
contamination and ensure safety and quality of the next product manufactured on the same
equipment.

2.0 SCOPE

This protocol is prepared for cleaning validation of manufacturing equipment’s used for xxxxx xx in
Lactonova.

3.0 CLEANING VALIDATION APPROACH

This is a concurrent validation since the cleaning procedure is approved and already in use.

4.0 CLEANING VALIDATION STRATEGY

The products are categorized in groups according to their formulation and equipment train. On the basis
of solubility and toxicity of the Active Pharmaceutical Ingredients (API) the worst case product identified.

Cleaning validation study of the cleaning procedures, are capable to remove the product residues to an
acceptable level. It assures that non-worst case present in the same group will also be cleaned by using
the same cleaning procedures. Cleaning validation requires three consecutive batches to be validated.

5.0 PRODUCT DESCRIPTION:

Liquid antiseptics are manufacturing in antiseptic line of Lactonova Pharma. These manufacturing
equipment also used for all other products. This protocol covers manufacturing of Lactonova Pharma.
The Solubility and Toxicity (LD50) of API given in following table:-

Product API Case Selection Criteria

High Toxicity (LD50 = 2000 mg/kg oral rat)

xxxxxxxxxxx Xxxxxxxx
Solubility (Soluble in cold water)

6.0 EQUIPMENT DESCRIPTION

The equipment name and Equipment identification numbers are given in table 1. Manual cleaning
procedures are used for cleaning of the equipments. Rinse sample will be taken from the predefined
sampling locations mention in sampling plan given in annexure I.
 Lactonova Nutripharm Pvt Ltd PROTOCOL No.
Quality Assurance Department CVP-LNP-XXX
xxxxxxxx Manufacturing Equipment Cleaning
Page 4 of 5
Validation Protocol

Table 1: Equipment Details

Equipment Name Equipment ID Reference SOP

EQ/PRD/007 SOP-PRD-033
EQ/PRD/008 SOP-PRD-033
EQ/PRD/009 SOP-PRD-033
EQ/PRD/016 SOP-PRD-034
EQ/PRD/016 SOP-PRD-034
EQ/PRD/016 SOP-PRD-034
EQ/PRD/016 SOP-PRD-034

7.0 RESPONSIBILITY

The following personnel are responsible for the execution of this protocol:-

 QA Validation: To prepare protocol and report for Cleaning Validation. To perform Cleaning
Validation sampling and submit the samples to QC.
 Production Supervisor: To communicate production schedule to QA/QC and facilitate for
sampling and ensure cleaning of equipment as per the cleaning procedure.
 Machine Operator: To perform equipment cleaning as per the cleaning procedure.
 QC Analyst: To perform cleaning validation sample analysis.

8.0 CLEANING PROCEDURE

The approved cleaning procedures as per their respective equipment SOPs as mentioned in Table-1.

9.0 DESCRIPTION OF SAMPLING PROCEDURE

Sampling Technique

The rinse samples will be collected from the equipment’s for nonspecific testing.

Procedure for Sampling

Rinse sampling for Non-specific testing

For Nonspecific testing (pH, Conductivity, and Oxidizable substances) rinse sample will be collected in
clean bottle along with blank. Testing will be performed as per sampling plan given in Annexure-I (Page
1/3).

Swab sampling for Microbial testing

Microbial swab samples from the equipment shall be collected for microbial testing, dirty equipment hold
time & clean equipment hold time testing. Sterile swabs shall be used for microbiological swab sampling.
Testing will be performed on these samples as per sampling plan given in annexure I (Page 2/3 & 3/3).

10. TEST FUNCTIONS AND ACCEPTANCE CRITERIA

A: Visual Inspection
 Lactonova Nutripharm Pvt Ltd PROTOCOL No.
Quality Assurance Department CVP-LNP-XXX
xxxxxxxx Manufacturing Equipment Cleaning
Page 5 of 5
Validation Protocol

Inspection of equipments to be performed visually at the end of the cleaning procedure. The visible
internal equipment surfaces and all parts should be optically free from residue.

B: Micro test

Micro test of swab sample shall be performed by microbiology section. The microbial results Total aerobic
count should not more than 100 cfu/ 100 cm2, Total combined yeasts & molds should not more than
100 cfu/ 100 cm2 .

D: Non-specific Testing

Non-specific testing (pH, Conductivity, and Oxidizable substances) of rinse sample will be performed.
The pH should be 5 to 7, Conductivity NMT 1.3 µS and for the oxidizable substances, the solution should
remain faint pink in rinse sample.

11.0 HOLD TIME OF DIRTY EQUIPMENT (BEFORE CLEANING)

Dirty equipment hold time studies will be performed as per the availability of equipment for the study.
Sampling & Testing will be performed as per sampling plan given in Annexure-I (Page -3/3; Table-A).

12.0 CLEANED EQUIPMENT HOLD TIME

To validate cleaned equipment hold time, equipment to be holded after cleaning for specific period of
time. Clean equipment hold time studies will be performed as per the availability of equipment. Sampling
& Testing shall be performed as per sampling plan given in Annexure-I (Page -3/3; Table-B).

13.0 ANNEXURE

Annexure I : Sampling plan