SOP for Sanitization of FFS Area

1.0 PURPOSE:

This document deals with the procedure for sanitization of the FFS area (Manufacturing and Filling area).

2.0 SCOPE:

Applicable for area sanitization of the core area of FFS Department.

3.0 RESPONSIBILITY:

Form Fill Seal department staff

4.0 ACCOUNTABILITY:

Head of Department

5.0 PROCEDURE:

NOTE: Follow the SOP for preparation of the disinfectant solution.
5.1 Clean the Filling area in the following sequence.
5.1.1 Suspension manufacturing area / Airlock.
5.1.2 Filling area.
5.1.3 Autoclave cooling zone.
5.1.4 DHS cooling zone.
5.1.5 Filtration area.
5.1.6 Sterile corridor.
5.1.7 Change room III, II
5.1.8 Return change room I
5.2 Clean the Manufacturing area in the following sequence.
5.2.1 DHS Loading Area.
5.2.2 Day Material stores.
5.2.3 Manufacturing area.
5.2.4 Autoclave loading area.
5.2.5 Wash area.
5.2.6 Change Room III, II.
5.3 Pick up the scrap and keep it in the waste bin. The waste bin should be kept clean and closed all the time.
5.4 Remove the spilled liquid if any, by a vacuum cleaner.
5.5 Immediately clean the area by using lint-free duster soaked with disinfectant solution.
5.6 Once in a shift (At the start of the activity)
5.6.1 Clean all equipment with 0.2µ filtered 70% IPA.
5.6.2 Swab the entire floor with disinfectant solution (2% Bacillocide / 2.5% Benzyl Septol / 5% Virosil ).
5.7 Once in a day.
5.7.1 Use 2% Bacillocide / 2.5% Benzyl Septol / 5% Virosil for sanitation.
5.7.2 Clean the walls, doors with disinfectant solution.
5.7.3 Clean the waste bin with disinfectant solution.
5.7.4 Clean the table and chair from all sides with disinfectant solution.
5.7.5 Clean the external surface of DHS with disinfectant solution.
5.7.6 Clean the external surface of Autoclave with disinfectant solution.
5.7.7 Clean the Switchboards, Thermo Hygro-Clock, intercom and SOP stands with disinfectant solution.
5.7.8 Clean the garment storage cabinet and pass box with disinfectant solution.
5.7.9 Clean All glass panel with 0.2µ filtered 70% IPA.
5.8 Once in a Week
5.8.1 Clean the Ceiling and external surface of pendant with disinfectant solution ( 2% Bacillocide / 2.5% Benzyl Septol / 5% Virosil ).
5.8.2 Clean the grills and light fixtures with 0.2µ filtered 70% IPA.

5.9 Once in a Month
5.9.1 Clean all floors, walls, ceiling and external surface of the pendant with 2% Phenol solution.
5.10 Cleaning of manufacturing and filling area after media filling:
5.10.1 After the completion of manufacturing and filling of media clean the floor, walls, doors, windows and pendants with 2% phenol solution.
5.10.2 Clean the outer surface of mfg. tanks, filter housings, holding tanks, product line and FFS machine with 2% phenol solution.
5.10.3 Swab all the accessories, tools, writing table, garment cubicle, and chair with 2% phenol solution.
NOTE: Follow the same cleaning and sanitization procedure for Change room I and Return Change room II of FFS filling area while leaving the department.
Follow the same cleaning and sanitization procedure for Change room I of FFS manufacturing area while leaving the department.
Before starting sanitization in manufacturing/ filling area, ensure that all containers are kept properly closed and labeled.
Every alternate week of the month, use 2.0% Bacillocide or 2.5% Benzyl Septol solution or 5% Virosil.

6.0 ABBREVIATIONS:

6.1 FFS: Form Fill Sea
6.2 IPA: Isopropyl Alcohol
6.3 %: Percentage
6.4 u. v.: Ultraviolet
6.5 µ: Micron
6.6 DHS: Dry Heat Sterilizer

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