Laminar Air Flow unit for aseptic process area-SOP

This Document describes (Standard Operating procedure) SOP for Laminar Air Flow i.e. Operation and Cleaning of Laminar Air Flow unit for aseptic process area.

SOP for Laminar Air Flow unit for aseptic process area

I. Purpose & Scope:

• The Purpose of this SOP is to lay down the procedure for Operation and Cleaning of Laminar Air Flow unit for aseptic process area (LAF)
• This procedure is applicable Engineering Department personnel for Sop for Operation and Cleaning of Laminar Air Flow unit for aseptic process area (LAF)

II. Responsibilities:

• All production personnel shall be responsible to follow and implement this SOP for Laminar Air Flow unit for aseptic process area

III . Introduction and Procedural Part:

Procedure:

• Ensure that LAF’s are continuously “ON” during operation.

Operating Procedure for LAF of Aseptic Process Area:

• Put ON the all LAF’S of Aseptic area minimum 30 min. before start of operation.
• Ensure that pressure differential of LAF is within limit i.e. 10 – 20 mm.
• Record the pressure differential reading in Annexure – I.
• Ensure that Sampling / Filtration / Filling / Sealing / blending area pressure differential are within limit.
• Record LAF start time and end time in annexure – I.

  Cleaning Procedure of Outer Surfaces:

• Clean upper horizontal and outer surface of aseptic process area LAF with lint free cloth and 70% filtered IPA.
• Note: If there is no activity then it will be cleaned before start of the activity and cleaning activity shall be noted in annexure – I.
• Cleaning of prefilters of aseptic process area LAF to be performed as per respective filter cleaning SOP.
• In case of power failures initiative should be taken as per respective power failure SOP.

Annexure -I

LAF Usage and cleaning Record

Date: