SOPs

Cleaning and sanitization of Flexible / braided tube/pipe

Cleaning and sanitization of Flexible / braided tube/pipe

OBJECTIVE: To establish a procedure for the use, cleaning, and sanitization of Flexible / braided tube/pipe.

SCOPE: This SOP is applicable to all sections of the formulation unit.

RESPONSIBILITY: 

  • Department in charge
  • Implementation of SOP.
  • Production Supervisor / Operator
  • To use, clean & sanitize tube as per SOP.
  • S&E Person
  • Clearance from S&E aspects.

ACCOUNTABILITY: Production HEAD

PROCEDURE:

Use a dedicated tube/pipe for water.

Use a dedicated tube/pipe for each product for product transfer.

Check the cleanliness of the tube before use.

Remove the cover from both ends of the tube.

Affix one end to the supply nozzle.

Drain the tube after use.

Coil the tube, close both ends with a cleaned polyethylene/aluminum foil cover, and hang it on the hook.

Cleaning:

Clean the tube/pipe on completion of the batch/process step.

Flush the tube/pipe with potable water by running the tap for 4 to 6 minutes.

Rinse the tube with purified water.

Drain the water. Cover both ends with cleaned polyethylene/aluminum foil.

Coil the tube and hang it on the hook.

Sanitization:

Sanitize the tube/pipe on a weekly basis.

Clean the tube/pipe on completion of the batch/process step.

Flush the filtered steam from one end of the previously cleaned tube/pipe for 5 to 7 minutes.

Rinse the tube with purified water.

Drain the water. Cover both ends with a cleaned polythene/aluminum foil cover.

Coil the tube and hang it on the hook.

ANNEXURE (S):

Nil

ABBREVIATION:

SOP  – Standard Operating Procedure.

S&E – Safety & Environment.

QA – Quality Assurance.

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube