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SOP for cleaning of vial filling machine and its parts

  • Objective
  • To lay down a procedure for cleaning of vial filling machine and its parts.
  • Scope
  • This SOP is applicable for cleaning of vial filling machine and its parts for Production dry powder Injection facility.
  • Responsibility
  • Production Officers / Executive.
  • Accountability
  • Production Head shall be accountable for the compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure
  • S.S.: Stainless Steel
  • Procedure
  • Cleaning in vials filling room.
  • Cleaning of vial filling machine during filling operation intervals (lunch break/tea break)
  • Collect broken glass vials, rejected vials and rubber stoppers from the machine base, if any in stainless steel trays.
  • Clean and disinfect the machine base and out feed turntable by wiping with lint free duster soaked in 70% Isopropyl Alcohol.
  • Open the glass panel of powder filling machine.
  • After daily vial filling operation
  • Open the glass panel of powder filling machine.
  • Collect broken glass vials, rejected vials and rubber stoppers if any from machine base in stainless steel trays and transfer to the washing & sterilization area through pass box.
  • Clean the machine base, delrin star wheel, delrin guides, S.S. rejection collection box by sponge piece covered with lint free duster soaked in Water for Injection.
  • Clean and disinfect the machine base by wiping with lint free duster soaked in disinfectant solution.
  • Clean and disinfect the conveyor and in-feed, out-feed turntable by wiping with sponge piece covered with lint free duster soaked in disinfectant solution.
  • Cleaning of machine at the end of campaign /after three days of production / Product change over
  • Open the glass panel of vial filling machine.
  • Remove the main hopper and intermediate hopper from machine body and keep it in stainless steel trolley.
  • Remove the powder-dosing wheel from machine body and keep it in same trolley.
  • Remove the Rubber stoppers hopper from machine and keep it in stainless steel trolley.
  • Clean the dismantled machine parts from vacuum hosepipe before transferring them to stainless steel trolley.
  • Remove the hosepipe and vacuum line filter from the machine and keep it in stainless steel trolley.
  • Transfer the machine parts through stainless steel trolley from vial filling room to cooling zone.
  • Take out the Aspirator Container through Pass Box.
  • Transfer the machine parts to equipment washing and sterilization area for further cleaning.
  • Clean and disinfect the in-feed turntable, out-feed turntable and its conveyor by wiping with sponge (covered with lint free duster) soaked in disinfectant solution.
  • Clean and disinfect the machine base by wiping with sponge piece covered with lint free duster soaked in disinfectant solution.
  • Clean and disinfect the glass panel of vial filling machine by wiping with sponge (covered with lint free duster) soaked in disinfectant solution.
  • Take care that electrical cable and sensors do not come in contact with any solution.
  • Cleaning in equipment washing and sterilization room
  • Cleaning of Main Hopper, Intermediate hopper & Rubber stopper hopper
  • Dismantle the Main hopper, intermediate hopper & rubber stopper hopper and wash three times by water for injection. In every wash approximately 15 liter water for injection is consumed.
  • Clean the main hopper, intermediate hopper and rubber stopper under tap in S.S sink of equipment wash trolley by water for injection.
  • Rub the surface of hoppers with a lint free duster and wash again by water for injection till visually clean.
  • Finally wash the main hopper, intermediate hopper rubber stopper with water for injection under tap in S.S. sink of equipment wash trolley.
  • Flush the hoppers with Water for Injection and collect the 100 ml wash water sample and inspect visually for particulate matter.
  • Send the sample of rinse water to Quality Control, along with the request for checking of chemical residue, endotoxin and Particulate matter in wash water (Specimen of request attached as Annexure-2).
  • In case wash water sample fails to meet the predetermined acceptance criteria, repeat the cleaning procedure, following step no. 7.1.2 to 7.1.5 and again send the rinse water sample to Quality Control.
  • After cleaning assemble the main hopper and intermediate hopper under Laminar Air Flow in equipment washing & sterilization area.
  • Cleaning of Dosing wheel, pistons and other machine parts.
  • Clean the Dosing wheel, pistons and other machine parts under tap in S.S sink of equipment wash trolley by Purified water till visually clean.
  • Rub the surface of dosing wheel and other machine parts with a lint free duster and wash again by Purified water till visually clean.
  • Finally wash the dosing wheel, pistons and other machine parts with Water for Injection under tap in S.S. sink of equipment wash trolley.
  • Rinse the dosing wheel and pistons separately with Water for Injection.
  • Collect 100 ml wash water sample from rinsed Water for Injection of dosing wheel (along with pistons) individually and inspect visually for particulate matter.
  • Send the sample of rinse water to Quality Control, along with the request for checking    of chemical residue, endotoxin and Particulate matter in wash water (Specimen of request attached as Annexure-2).
  • In case wash water sample fails to meet the predetermined acceptance criteria, repeat the cleaning procedure, following step no. 7.2.1 to 7.2.5 and again send the rinse water sample to Quality Control.
  • After cleaning assemble the main hopper and intermediate hopper under Laminar Air Flow  in equipment washing & sterilization area.
  • Clean the Aspirator Container with WFI and transfer it to Critical Area.
  • Clean the hosepipe and finally disinfect the inner surface of pipes by rinsing with 20% Virosil Pharma and transfer to critical area through Pass Box.
  • Cleaning Record of Powder Filling Machine Parts (specimen attached as Annexure-1).
  • Record the details of cleaning operation in the operation and cleaning record as per SOP and get it checked by concerned supervisor/officer.
  • Frequency of cleaning: At the end of campaign / after three days of production /during product change over.
  • Forms and Records (Annexures)
  • Cleaning record of powder filling machine parts – Annexure-1.
  • Request for Endotoxin /Particulate Samples of Powder Filling Machine – Annexure-2.
  • Line clearance request cum report – Annexure-3.
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP

Annexure-1

Cleaning record of powder filling machine parts 

Date Cleaning

Done By

Visible Observation

(Clean/Not Clean)

Cleaning

Checked By

Product

Change Over/

Same Product

Rinse Water

Sample Approved

By QA D. (Yes/No)

Remarks

(If any)

             

Approved By

Production                                                                                                            QC Officer/Chemist

Annexure-2

Request for Endotoxin /Particulate Samples of Powder Filling Machine  

To:  Microbiology – QC.                                                                                 Date: ———————–

Please analyze the rinse water samples for Particulate matter and Endotoxin of the powder filling machine parts selected below and give the results.

Sampled By (production) ………………………       Sample Received By (QAD) …………………..

S.

No

Equipment Name Results Decision Tested By
Particulate Endotoxin
Visible LBPC
01 Main Powder Hopper ≥10µ Cleaned / Not Cleaned
≥25µ
02 Intermediate Powder Hopper ≥10µ Cleaned / Not Cleaned
≥25µ
03 Powder dosing Disk-I (8mm),(0.25 / 0.5)g. ≥10µ Cleaned / Not Cleaned
≥25µ
04 Powder dosing Disk-II (10mm),(1.0 / 1.5)g ≥10µ Cleaned / Not Cleaned
≥25µ
05 Pistons (24Nos.) ≥10µ Cleaned / Not Cleaned
≥25µ
06 Rubber Stopper Hopper ≥10µ Cleaned / Not Cleaned
≥25µ
07 Tool Box ≥10µ  

 

Cleaned / Not Cleaned
≥25µ
08 Scrapper Blades ≥10µ Cleaned / Not Cleaned
≥25µ
09 Miscellaneous ≥10µ Cleaned / Not Cleaned
≥25µ
10 Water used for rinsing ≥10µ Cleaned / Not Cleaned
≥25µ
  • Select the equipment by marking Tick ( ) on Sr. No.
S. No. Test Acceptance Criteria
01 Particulate (Visible) Free from visible particles
02 Liquid Borne Particle Count ≥10µ – NMT 60/ml

≥25µ – NMT 6/ml

03 Bacterial Endotoxin Test NMT  0.125 Eu/ml

Conclusion: The vial filling machine parts are ready / not ready for processing of next batch.

Production Officer/Chemist                                                                                 QC Officer/Chemist

Annexure-3

Line clearance request cum report 

To: Quality Control Department

From: Production Department

Please analyze the samples for line clearance of the Vial Filling Machine Parts selected below and give the results in ppm of the last product processed in the equipments, present in the rinse water sample.

Last Product Processed: …………………..                                          Batch No. ……………………

Next Product Planned: ……………………..                                         Batch No. ……………………

Sampled By (production) …………………..   Sample Received By (QAD) …………………………

S. No. Equipment Name Results Decision Tested By
Appearance Analytical Result
01 Main Powder Hopper Cleaned / Not Cleaned
02 Intermediate Powder Hopper Cleaned / Not Cleaned
03 Powder dosing Disk-I (8mm),(0.25 / 0.5)g. Cleaned / Not Cleaned
04 Powder dosing Disk-II (10mm),(1.0 / 1.5)g Cleaned / Not Cleaned
05 Pistons (24Nos.) Cleaned / Not Cleaned
06 Rubber Stopper Hopper Cleaned / Not Cleaned

Select the equipment by marking Tick ( ) on Sr. No.

  • Limit: NMT 10ppm of the last product processed in the equipments.

Production Officer/Chemist

Conclusion: The vial filling machine is ready/not ready for processing of the next product. ……….

QC Officer/Chemist.

Approved By

Production                                                                                                            QC Officer/Chemist

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