SOP for Operation and Cleaning of Powder Sampling Booth

OBJECTIVE

To lay down a procedure for proper use and cleaning of the Powder Sampling Booth.

SCOPE

The procedure applies to the Powder Sampling Booth in the Sampling room located in the warehouse at PharmaInfo Limited.

RESPONSIBILITY

It is the responsibility of the operator to follow the procedure

It is the responsibility of the supervisor to ensure that the procedure is followed.

PROCEDURE

Startup

• Ensure that the room is clean and free from any previously sampled materials.
• Switch on the power supply and the fluorescent light.
• Ensure the equipment is in a clean and sanitary state.
• Wipe the walls with 70% isopropyl alcohol or 70% ethanol.
• Disinfect with the disinfectant of the day. When a hypochlorite disinfectant is used a second wiping with purified water is needed to remove residual chlorine.
• Start blowers at least 15 minutes before the commencement of operations.
• Record differential pressure across the HEPA filter in a log book provided, initial readings are in the range of 8 mm – 12 mm.
• Ensure adequate protective gear is worn by operating personnel.
• Do not clutter the work area as this might cause disruption to the airflow, resulting in turbulence, possible cross-contamination, and or breach of contamination.

ALSO READ: SOP for Pass Box for Raw Materials

Shut down

• Disconnect all utilities.
• Switch off the motor blower.
• Clean any equipment used in the work area.
• Clean the entire unit, especially the working zone.
• Switch off the Fluorescent light.
• Keep entry curtains closed always.

Precautions

• All objects placed in the aseptic zone should be free from gross bio-burden and not release particles.
• While cleaning does not damage the HEPA filter (ensure that the nozzles of the vacuum cleaner are never pointed towards the HEPA filter).
• Do not store anything on top of the unit.

ABBREVIATIONS

HEPA: High-Efficiency Particulate Air

QA: Quality assurance

QC: Quality Control

REVISION HISTORY

Nil

ALSO READ: SOP for Operation of Dispensing Booth