SRI VYJAYANTHI LABS PVT. LTD.

PLOT NO. 27/A, JNPC, PARAWADA (M) VISAKHAPATNAM – 531 019.

Doc No.: SVLL/PD/SOP/034-00

Standard Issue date : Effective date:
Operating
Procedure Review date :
Supersedes: Nil
Page 1 of 3
Department: Production
TITLE: PROCEDURE FOR ZONING AREA

1.0 Purpose:
To describe the procedure for zoning areas in Production block.

2.0 Scope:
This procedure is applicable for segregation of zoning areas in manufacturing Block-A at Sri
Vyjayanthi Labs Pvt. Ltd.
3.0 Definitions: Nil

4.0 Responsibility:
Production in-charge and operators shall responsible and follow the SOP.

The department head shall responsible for reviewing the SOP.

Quality Assurance shall responsible for compliance with the SOP.

5.0 Procedure:
5.1 The zoning areas in production block-A has identified the same to avoid cross
contamination.
5.2 The degree of hygiene control in the facility depends on the type of the operation and the
analysis of the potential risk.
5.3 The more sensitive of the product, the more important it is to be given and separate the
facility into different hygiene areas.

Prepared by Reviewed by Approved by

Name V.MADHAVA RAO
Designation EXECUTIVE - PD MANAGER - PD MANAGER - QA

Sign & Date

 SRI VYJAYANTHI LABS PVT. LTD.
PLOT NO. 27/A, JNPC, PARAWADA (M) VISAKHAPATNAM – 531 019.

Doc No.: SVLL/PD/SOP/034-00 Page 2 of 3

TITLE: PROCEDURE FOR ZONING AREA

5.4 Each manufacturing operation requires an appropriate environmental cleanliness level in

order to minimize risks of contamination.
5.5 The facility is divided into areas with different allowable processing steps, different rules
or procedures for persons who are allowed to entry with different levels of cleanliness
5.6 The areas are classified as Low, Medium and High hygiene areas.
Types of Zones:
5.6.1 High hygiene area (Drying, Milling, Sifting, Blending and packing area)
5.6.2 Medium hygiene area (Crystallization and Buchner area)
5.6.3 Basic / Low Hygiene area (Corridor area)
5.7 High hygiene area:
High hygiene areas are those where dry material of the product is exposed to environment
and personnel and to pathogenic growth in this area operating practices relating to
personnel, product are to be controlled to minimize contamination.

5.8 Medium hygiene area:

Medium hygiene areas in which the material will be under washing treatment and in wet
condition.
5.9 Basic hygiene area /Low Hygiene area:
Low Hygiene areas are those where the material and men movement is present.

Prepared by Reviewed by Approved by

Name V.MADHAVA RAO
Designation EXECUTIVE - PD MANAGER - PD MANAGER - QA

Sign & Date

 SRI VYJAYANTHI LABS PVT. LTD.
PLOT NO. 27/A, JNPC, PARAWADA (M) VISAKHAPATNAM – 531 019.

Doc No.: SVLL/PD/SOP/034-00 Page 3 of 3

TITLE: PROCEDURE FOR ZONING AREA

Hygienic Zoning
lcif
Ca

ica

Zo
tio

ne
of
n

6.0 Related Documents: Nil

7.0 Revision Record:

Date Revision Status Details of Revision Remarks
00 First issue --

Prepared by Reviewed by Approved by

Name V.MADHAVA RAO
Designation EXECUTIVE - PD MANAGER - PD MANAGER - QA

Sign & Date