Preparation and filtration of sanitization solution

This Document describes (Standard Operating procedure) SOP for Preparation and filtration of sanitization solution for Aseptic process area

SOP for Preparation and filtration of sanitization solution.

I. Purpose & Scope:

• The Purpose of this SOP is to lay down the procedure for Preparation and filtration of sanitization solution for Aseptic process area.
• This procedure is applicable Engineering Department personnel for Sop for Preparation and filtration of sanitization solution for Aseptic process area.

II. Responsibilities:

• All production personnel shall be responsible to follow and implement this SOP for Preparation and filtration of sanitization solution for Aseptic process area.

III. Introduction and Procedural Part:

Procedure for Preparation and filtration of sanitization solution :

Ensure that the sanitization solution of the day is prepared as per below procedure.

• Take required quantity of water for injection in a clean SS vessel in unit preparation room.
• Cool the WFI.
• Dilute the disinfectants in WFI and mix in the proportion as per following table.

• After mixing is completed, transfer the sanitization solution to a clean pressure vessel. Take the SS pressure vessel to unit preparation room.
• To avoid development of mutants, Dettol, Savlon should be used in rotation

Filtration & Transfer of Disinfectant Solution to Aseptic Process Area:

• Ensure that filtration assembly comprises of the following.
  • 1. Filter holder with 0.2 m membrane filter and 2 m pre-filter.
    2. Silicon tubing 2 Nos, SS clips 2 Nos, SS vessel, which has been sterilized.
• Ensure that in the wash area side following clean (unsterilized) articles are available – 1 No silicon tube, SS clips 3 No and pressure vessel 1 No.
• Ensure that nitrogen is available for filtration
• Connect the silicon tube in the following order.
• Nitrogen filter outlet and inlet of pressure vessel (in the wash area) containing disinfectant solution.
• The silicone tubing of inlet of filter holder (aseptic area) to outlet of pressure vessel (in the wash area) through the SS pipe.
• Outlet of filter holder to the SS vessel (inside the sterile area).
• Open the nitrogen inlet valve from the nitrogen line and adjust in a manner that the pressure build up in the pressure vessel is between 1.0 to 1.5 kg/cm².
• Filter disinfectant solution through filter assembly under nitrogen pressure in a clean sterilized SS vessel (inside the sterile area).
• Close the nitrogen inlet valve and diffuse the nitrogen pressure in the pressure vessel (in the wash area) by opening the vent valve.
• Disconnect the nitrogen silicon tubing from the pressure vessel (in the wash area) and the silicon tubing from the filter holder.
• Record the operation in filtration and fitter integrity record.
• Preparation and filtration of sanitization solution shall be done according the standard operating procedure

Assembling of Filter Holder : 

• Place the support ring over slot in the base plate meant for it.
• Place membrane support mesh plate over support ring in the place meant for it.
• Place the membrane filter over the support mesh plate.
• Wet the surface of the membrane support mesh & filter membrane with water for injection.
• Remove the folding in the membrane by lifting the membrane and gradually placing it over the membrane support mesh in a manner so that no folding is formed.
• Place the pre-filter (142 mm) over the membrane filter (142 mm) and wet it with water for Injection.
• Place the top plate over the prefilter properly, tighten the bolts.
• Connect the silicon tubing in the following order.
• Connect compressed air tubing to inlet of pressure vessel containing solution.
• Connect outlet of pressure vessel to inlet of membrane filter holder though silicon tubing.
• Connect outlet of membrane filter holder to inlet SS vessel though silicon tubing.
• Open compressed air valve from the pendant and adjust in a manner that the pressure built up in the pressure vessel is between 1.0 to 1.5 kg/cm2
• Filter the solution through filter assembly under compressed air pressure in a clean sterilized SS vessel (inside the sterile area).
• Close the compressed air inlet valve and diffuse the compressed air pressure in the pressure vessel by opening the vent valve.
• Disconnected the compressed air silicon tubing from the pressure vessel and the silicon tubing from the filter holder.
• Record the Filtration in Respective format

Filter integrity by Bubble point test :

• Wet the filter to be tested with water for Injection.
• Place the wetted filter in the appropriate housing.
• Connect the outlet from compressed air pressure regulators to inlet of membrane filter holder though silicon tubing.
• Connect the silicon tubing from outlet of membrane filter holder into a beaker filled with water for Injection.
• Starting from zero pressure, gradually increase the pressure to the test filter using the pressure regulator.
• Observe the submerged end of the silicon tubing for the production of bubbles.
• Record bubble point test pressure in respective format.

Standard bubbles points pressure for filter: