SOP

  1. 1. Objective:

To lay down a procedure for cleaning and sterilization of bulk storage tank during batch to batch and product to product cleaning.

  1. Scope:

This procedure is applicable for cleaning and sterilization of bulk storage tank used for storage of semisolid bulk product like cream, ointment.

  1. Responsibility:

Production department

  1. Procedure:

4.1 Type A cleaning for batch to batch change over:

4.1.1 Heat the storage tank using raw steam at 3 kg/cm2 in jacket until temperature reaches up to 1210C. Hold the storage temperature at this temperature for 15 minutes.

4.1.2 Drain out melted jelly/product residue from the storage tank.

4.1.3 Take approx. 200 litre water in CIP tank and heat up to 80-900C

4.1.4 Circulate the water from step 4.1.3 in the bulk storage tank at 800C for 15 minutes.

4.1.5 Ensure functioning of spray ball during this process.

4.1.6 Check the conductivity of water returned from bulk storage tank via return line.

4.1.7 Conductivity of water should be less than 1.3µs for recirculation of same water to the bulk storage tank for cleaning purpose. If conductivity is observed above the limit then water shall be drained out to the direct drain outlet of CIP unit.

4.1.8 After above cleaning, recirculate purified water in CIP line to complete removal of the residue of the previous batch manufactured.

4.1.9 Conductivity of water is checked by conductivity meter installed with CIP unit.

4.1.10 After removal of product residue, charge 20 litre WFI in CIP tank and transfer to bulk storage tank after filtration through 0.22-micron filter. Rinse bulk storage vessel and drain out WFI through direct drain outlet of CIP unit.

4.1.11 Affix the clean label on storage tank.

4.1.12 For batch to batch cleaning, 5 batches of same product can be manufactured.

4.2 Type B cleaning for product to product change over:

4.2.1 Heat the storage tank using raw steam at 3 kg/cm2 in jacket until temperature reaches up to 1210C. Hold the storage temperature at this temperature for 15 minutes.

4.2.2 Drain out melted jelly/product residue from the storage tank.

4.2.3 Now add 2% NaOH solution to wash the storage tank.

4.2.4 Apply the further procedure as mentioned in Type A cleaning.

4.2.5 Collect the rinse sample of the storage tank after rinsing with WFI from CIP tank and send to QC for residual analysis.

4.2.6 Affix the clean label on storage tank.

4.3 Sterilisation of bulk storage tank:

4.3.1 Close the valve of storage tank and apply pure steam into the chamber of tank.

4.3.2 Maintain the temperature of steam above 1210C and pressure more than 1.6 bar.

4.3.3 Hold the temperature and pressure for 20 minutes.

4.3.4 Affix the status label on equipment.

4..3.5 Maintain the cleaning and sterilisation log for storage tank.

  1. Abbreviations:

SOP: Standard operating procedure

CIP: Cleaning in place

WFI: Water for injection

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