SOP for Deactivation of Rejects and Left over powder

This Document describes (Standard Operating procedure) SOP for Deactivation of Rejects and Left over powder.

SOP for Deactivation of Rejects and Left over powder

I. Purpose & Scope:

• The Purpose of this SOP is to lay down the procedure for Deactivation of Rejects and Left over powder.
• This procedure is applicable to production Department personnel for Deactivation of Rejects and Left over powder.

II. Responsibilities:

• All production personnel shall be responsible to follow and implement this SOP.

III . Introduction and Procedural Part :

PROCEDURE:

• Depending upon the subject of application, deactivation procedure can broadly be divided into

Four categories:-

• For Human/Personnel.
• For Material.
• For Machinery and Change Parts.
• For Miscellaneous Item

Deactivation of Human/Personnel:

• Follow the entry exit SOP of cephalosporin block.
• Keep your mask and hand gloves in polythene bag with proper identity and keep it in the cupboard of that area and at the shift end put it in the waste bin.
• Clean the manufacturing footwear in washing area.
• Move to the (Manufacturing) change room, remove the over gown/boiler suit and keep it in the provided cupboard/locker, and at the shift end put it in the used dress bin.
• Remove the manufacturing footwear and keep in respective locker.
• Cross the crossover bench and wear factory foot wears.
• Wash hands with 1.0 % w/v Sodium bicarbonate solution.
• Move to the primary change room.
• Remove the factory footwear, apron and cap, put it in the locker. Wear street dress in case of Workmen. In case of visitor, put it in used garment box.
• Cross the crossover bench, wear the street footwear and go out.

Deactivation of Material:

• For deactivation of material/container which is to be destroyed, shall follow the procedure, disposal of waste.
• In case of raw material shall be treated with 1.0 % sodium hydroxide (NaOH) solution.
• Prepare the 1.0 % sodium hydroxide (NaOH) solution.
• Treat the material with prepared solution in washing area.
• Then remove it from area to outside.

Deactivation of Machinery and change parts:

• For Deactivation of machine and its change parts do the following procedure before sending it to outside of Cephalosporin (Generally, this will be required for taking machine & its part to maintenance area for maintenance work.)
• Wipe outer surface of machine with 1.0 % sodium hydroxide (NaOH) solution.
• Clean all the change parts & deactivate it by dipping it in 1.0 % sodium hydroxide (NaOH) solution.

Deactivation of Miscellaneous Item:

• Apron and over gown before sending the apron and over gown to washing section, deactivate it with by dipping in 1.0 % sodium hydroxide (NaOH) solution.
• Clean S.S. accessories and plastic container with raw water in Cephalosporin washing area. Again wash it with 1.0 % sodium hydroxide (NaOH) solution for deactivation purpose before sending it outside.
• Maintain records of deactivation in Annexure I
• Maintain preparation and usage record of 1.0 % NaOH in Annexure II.
• Mopping of store rooms shall be done at the time of product change over and also at the time of closing of dispensing operation for the day at the end of the using weekly disinfectant solution.

Annexure :

Annexure I : Deactivation of rejects and left over powder.

Annexure II : Preparation and usage record of 1.0% NaOH

ANNEXURE-I

Deactivation of rejects and left over powder.

ANNEXURE-II

Preparation and usage record of 1.0% NaOH