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COVALENT LABORATORIES PRIVATE LIMITED
Department 1 of 5
GUNDLAMACHANOOR
Production
PROTOCOL FOR ESTABLISHMENT OF UV LIGHT
EFFICIENCY
Protocol Number GSP/STR/18/XX Revision No. 00 Effective Date
Block Sterile Production Block

PROTOCOL
FOR
ESTABLISHMENT
OF
UV LIGHT EFFICIENCY

Format No. QSP.35/F04//VP,Revision No.09, Effective date:14.02.2015.

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COVALENT LABORATORIES PRIVATE LIMITED
Department 2 of 5
GUNDLAMACHANOOR
Production
PROTOCOL FOR ESTABLISHMENT OF UV LIGHT
EFFICIENCY
Protocol Number GSP/STR/18/XX Revision No. 00 Effective Date
Block Sterile Production Block

PROTOCOL APPROVAL:

Prepared by

NAME DESIGNATION SIGNATURE DATE

CH. Kanchan Kumar Sr. Chemist - SPR

Checked by

NAME DESIGNATION SIGNATURE DATE

M.Jayachandar Executive - QA

G. Gopinath Reddy Sr. Executive - MIB

N.N.Mallikarjuna Rao Sr. Manager - SPR

Approved by

NAME DESIGNATION SIGNATURE DATE

N.V.K.Subba Reddy Manager - QA

Format No. QSP.35/F04//VP,Revision No.09, Effective date:14.02.2015.

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COVALENT LABORATORIES PRIVATE LIMITED
Department 3 of 5
GUNDLAMACHANOOR
Production
PROTOCOL FOR ESTABLISHMENT OF UV LIGHT
EFFICIENCY
Protocol Number GSP/STR/18/XX Revision No. 00 Effective Date
Block Sterile Production Block

TABLE OF CONTENTS

S. No. DESCRIPTION PAGE NO.

1.0 Objective 4
2.0 Scope 4
3.0 Site of Study 4
4.0 Responsibility 4
5.0 Validation Procedure 5
6.0 Acceptance Criteria 5
7.0 Evaluation of results 5
8.0 Report and conclusion 5
9.0 Abbreviations 5
10.0 Annexures 5

Format No. QSP.35/F04//VP,Revision No.09, Effective date:14.02.2015.

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COVALENT LABORATORIES PRIVATE LIMITED
Department 4 of 5
GUNDLAMACHANOOR
Production
PROTOCOL FOR ESTABLISHMENT OF UV LIGHT
EFFICIENCY
Protocol Number GSP/STR/18/XX Revision No. 00 Effective Date
Block Sterile Production Block

1.0 Objective:
The main objective of this protocol is to evaluate the UV light efficiency while transferring of
articles to critical area through dynamic pass box.

2.0 Scope:

This protocol applies to validation of UV light efficiency while transferring of articles to

critical area through dynamic pass box in Sterile block at Covalent Laboratories Private
limited.

3.0 Site of study:

The Dynamic Pass Box (Equipment ID No: DPB - 2502) containing UV light is located in
cleaning and sterilization room of the sterile production block. The sterilization area is
designed as per the specifications for cleanliness Grade C (class - 10,000). The equipment is
located such that, it can be attended easily for routine operational, monitoring and
maintenance purpose. Dynamic Pass Box having two doors, one door of the Dynamic Pass
Box opens into the controlled area and the other door opens into aseptic area .

4.0 Responsibility:

S. No Department Responsibility

01. Sr. Chemist - SPR Protocol preparation, execution of validation activity.

02. Executive - QA

03. Sr. Executive - MIB Review of protocol and monitoring of validation

activity.
04 Sr. Manager - SPR

Protocol Approval
05 Manager - QA

Format No. QSP.35/F04//VP,Revision No.09, Effective date:14.02.2015.

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Page
COVALENT LABORATORIES PRIVATE LIMITED
Department 5 of 5
GUNDLAMACHANOOR
Production
PROTOCOL FOR ESTABLISHMENT OF UV LIGHT
EFFICIENCY
Protocol Number GSP/STR/18/XX Revision No. 00 Effective Date
Block Sterile Production Block

5.0 Validation procedure:

5.1 The dynamic pass box shall be cleaned before placing the articles in it using lint free
mopping duster with disinfectant.
5.2 The articles shall be sanitized with disinfectant for 5 minutes and avoid contact with the
articles for 3 minutes.
5.3 After 3 minutes the sanitized articles shall be placed in the dynamic pass box.
5.4 The dynamic pass box contains UV light, allow the articles to expose under UV light for
30 minutes.
5.5 Collect the surface monitoring sample for every 5 minutes. Sample shall be collected by
microbiologist.
6.0 Acceptance Criteria:

7.0 Evaluation of results:

After completion of the validation activity evaluate the results.

8.0 Report and conclusion

After completion of validation a summary report shall prepared, approved and concluded.

9.0 Abbreviations :

GSP : General Study Protocol

UV : Ultra Violet
SPR : Sterile production
QA : Quality Assurance
MIB : Microbiology
DPB : Dynamic Pass Box
STR : Sterile

Format No. QSP.35/F04//VP,Revision No.09, Effective date:14.02.2015.