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SOP For Discrete Batch System

This SOP outlines the standardized procedure for storing finished products in a discrete batch system, ensuring product traceability. Responsibilities are assigned to the Plant Officer, Shift Engineer, and QA Engineer for adherence and monitoring. Key procedures include storage tank management, batch formation, batch number allocation, and quality analysis before dispatch.

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32 views4 pages

SOP For Discrete Batch System

This SOP outlines the standardized procedure for storing finished products in a discrete batch system, ensuring product traceability. Responsibilities are assigned to the Plant Officer, Shift Engineer, and QA Engineer for adherence and monitoring. Key procedures include storage tank management, batch formation, batch number allocation, and quality analysis before dispatch.

Uploaded by

ridunicol001
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 4

DB - 01

SOP for Discrete Batch System Issue # 01


Issue Date:
01.03.2025
Page 3 of 3

1.0 Objective

This procedure establishes a standardized mechanism for the storage of finished


products and the allocation of discrete batch system, ensuring product traceability
throughout the supply chain.

2.0 Responsibility

The Plant Officer / Shift Engineer is responsible for adherence to this procedure.

The QA Engineer is responsible for the effective implementation and monitoring of


this procedure.

3.0 Procedure

3.1 Storage Tanks

The finished product is stored in four designated tanks with the following capacities:

Capacity
Tank Number
(Tons)
Tank # 01 100
Tank # 02 50
Tank # 03 100
Tank # 04 100

3.2 Batch Formation

 Each completely filled storage tank constitutes one batch.

 A batch is considered complete when the following minimum production


volumes are reached:

o Tank # 01, 03 & 04 → More than 80 MT

o Tank # 02 → More than 40 MT


DB - 01
SOP for Discrete Batch System Issue # 01
Issue Date:
01.03.2025
Page 3 of 3

3.3 Storage Tank Management

 Storage tanks should never be completely emptied to prevent corrosion. A


minimum pressure of 1 bar must be maintained in each tank.

 A storage tank should only be refilled once it is completely emptied to ensure


proper batch traceability.

3.4 Batch Number Allocation

Each fully filled storage tank is assigned a batch number based on the following
format:

AA-BB/CCCC

For example: 01-03/2025

Where:

 AA → Sequential batch number starting from 01, resetting to 01 after


reaching 99.

 BB → Manufacturing month in numerical format (e.g., 03 for March).

 CCCC → Manufacturing year (e.g., 2025).

3.5 Batch Record Maintenance

 The Shift Plant Officer is responsible for maintaining the Batch Number
Allocation & Traceability Sheet (FM-27).

 The following details must be recorded for each batch:

o Batch start time

o Total production hours


DB - 01
SOP for Discrete Batch System Issue # 01
Issue Date:
01.03.2025
Page 3 of 3

o KMnO₄ (Potassium Permanganate) and Soda Ash consumption

o Batch completion time

o Maintenance activities conducted during batch production

o Any abnormalities or shutdowns that occurred during batch


manufacturing

o General remarks

3.6 Batch Analysis

Each batch of Liquid CO₂ (LCO₂) must undergo quality analysis before final approval
for dispatch. The QA/QC Representative is responsible for performing the following
tests and recording the results in the Batch Analysis Report (FM-XX).

Parameters for Analysis:

 Purity (%): Minimum 99.90%

 Sulfur Dioxide (SO₂): <0.2 ppm

 Methyl Alcohol: <10 ppm

 Ethyl Alcohol: <20 ppm

 Water Vapor: <0.1 ppm

 Oil Films: None detected

 Total Volatile Hydrocarbons (as Methane): <20 ppm

 Carbonyl Sulphide: <0.1 ppm

 Nitrogen Oxides: <0.2 ppm

 Acetaldehyde: <0.2 ppm


DB - 01
SOP for Discrete Batch System Issue # 01
Issue Date:
01.03.2025
Page 3 of 3

 Sensory Tests: Odorless, Colorless, Tasteless

Batch Approval Criteria:

A batch will only be approved for release if all parameters meet the Acceptable
Quality Limits (AQL) stated above. Non-compliant batches must undergo corrective
actions, including potential reprocessing or rejection.

4.0 Related Records

Batch Number Allocation & Traceability Sheet (FM-27)

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