SOP for Cleaning of Octagonal Blender

In this post Standard Operating Procedure of SOP for Cleaning of Octagonal Blender in Pharmaceuticals is describe.

SOP for Cleaning of Paste Kettle 100 liter (Bectochem)

1.0 OBJECTIVE :

To lay down a procedure for cleaning of Octagonal Blender 3000 litre (SAAN).

2.0 SCOPE :

This procedure is applicable to the cleaning of Octagonal Blender 3000 litre (SAAN) in granulation area.

3.0 RESPONSIBILITY:

Production: Technical Associate/Officer /Executive/Assistant Manager

Head Production: To ensure execution & compliance

Head QA: To ensure the compliance

4.0 PRO CEDURE:

4.1 CLEANING :TYPE A

Change over from one batch to next batch of the same product with same potency and of similar product with ascending potency.

4.1.1 Remove “TO BE CLEANED” label and affix “UNDER CLEANING” label to

the machine with date and signature of the production officer.

4.1.2 Enter the cleaning start time in equipment sequential log book as per SOP.

4.1.3 Ensure that the main power supply is switched off.

4.1.4 Clean the step ladder, safety rod, blender base, body of blender and control panel by using clean dry lint free cloth.

4.1.5 Replace the “UNDER CLEANING” status label with “CLEANED” status label with date and signature of the Production Officer.

4.1.6 Enter the cleaning completion time in equipment sequential log book as per SOP.

4.2. TYPE B:

This is a cleaning procedure for Change over of product with different actives / color / descending potency or after maintenance of contact parts.

4.2.1 Follow the procedure from step 4.1.1 to 4.1.4

4.2.2 Cover all electrical panel with polyethylene bag.

4.2.3 Dismantle all the parts and lid of blender by unscrewing the bolt.

4.2.4 Clean inner and outer side of blender by using approx. 120.0 to 140.0 kg purified water.

4.2.5 Scrub outer part of blender, butterfly valve, step ladder, base, lid and safety rod with nylon scrubber.

4.2.6 Wash all the parts of blender by using approx.150.0 to 180.0 kg purified water. Rinse all the parts with approx. 100.0 to 120.0 kg purified water.

4.2.7 Dry inner portion and butterfly valve of blender by compressed air. Dry outer part, step ladder, base and safety rod by using compressed air followed by clean dry lint free cloth. Wipe the blender as well as all the cleaned parts with clean lint free cloth soaked in 70 % v/v IPA solution.

4.2.8 Assemble all the dismantled parts to the blender.

4.2.9 Remove the “UNDER CLEANING” label and affix “CLEANED” label with date and signature of the production officer.

4.2.10 Record the cleaning completion time in equipment sequential log book as per SOP.

5.0 ANNEXURE (S) :

Annexure I: Cleaning checklist of Octagonal blender.

6.0 REFERENCE (S):

SOP: Preparation, approval, distribution control, revision and destruction of Standard Operating Procedure (SOP).

SOP: Procedure for area line clearance.

7.0 ABBREVIATION (S) /DEFINITION (S) :

IPA : Iso Propyl Alcohol

SOP : Standard Operating Procedure

v/v : Volume/Volume