In this post Preparation Of Area Before And After Long Shut Down Sterile Area are described.


PREPARATION OF AREA BEFORE LONG SHUT DOWN

  1. Disconnect the Electric/Compressed air supply to the filling machine.
  2. Seal the Conveyor “Opening” towards the labelling room with sterile duster moistend with 5% phenol solution.
  3. Cover the compressed air housing having filters (ingersol/PALL) with Sterile Aluminium foil followed by Polyethylene sheet.
  4. Cover the vacuum pipes/compressed air pipes “Openings” with Sterile Aluminium Foil.
  5. Switch “off” the lights and Laminar flow hood.
  6. Tightly closed the internal doors of gruenburg oven and ETC Sterilizers. And seal with masking tape.
  7. Wrap the Isolated clean machines parts in Aluminium foil and store them in 2nd changing room.
  8. Lock the entry door of aseptic area and seal with tape. Post a sign “AREA CLOSED” on door.
  9. Close the external doors of Gruenburg/ETC sterlizers and switch “off” the electric supply from main switch. And seal with masking tape.
  10. Cover the vial/plug washing machines, L.F.H. and all S.S. trays with polyethlene sheet.
  11. Lastly lock the main door of Injectable area and give key to Security Officer.
  12. IN CASE OF CIVIL WORK

i. Seal the critical areas with Aluminium foil, butter paper and finally with Polyethylene sheet of following :-
  • All hepa filters
  • L.F.H.
  • Filling machine head, seal/rubber plugs containers and vial Turntable etc. (N.B. in case of reflooring, take out the seal/ Rubber plugs containers, S.S. racks, Tablets/balances/machine parts).
  • Vacuum/compressed air pipes 
  • All lights and electirc switches
  • Gruenburg oven and ETC sterilizers doors in dryer room.
ii. Finally cover the entire filling machine and LFH with dust proof nylon cloth


PREPARATION OF AREA AFTER LONG SHUT DOWN


1) Remove the covers and seals of covered parts of the machine as well as filters. Follow the SOP No. ___¬_4 - A____ i.e. preparation of area after maintenance.

2) In case of civil work procedure is attached.

PREPARATION OF ASEPTIC AREA AFTER CIVIL WORK 
BY SANITATION DEPARTMENT.

PROCEDURE :

Sterile Area after long shut down due to civil work including reflooring and painting will be handed over to Sanitation department for the preparation of Aseptic Area as first phase.

PART – 1 :  

GENERAL HAND DUSTING OF CEILING FIXTURES, 
WALLS AND DUST MOPPING OF FLOORS :

This is the outline of the method used for removing dust, and light soil from surfaces of all smooth finished walls, ceiling fixtures and floors.

A. MATERIALS NEEDED :
I) Clean fresh laundered lint
        Free dusters ………..12 Nos

        DRY ROOM l 1 duster for ceiling
l 2 duster for walls 

FILLING ROOM l 1 duster for ceiling
l 2 duster for walls 

        AIR LOCK l 1 duster for ceiling
l 2 duster for walls 

        CHANGING ROOMS l 1 duster for ceiling
l 2 duster for walls 

                I) EXTRA IF NEEDED
                II) Dust Mop (new)
                III) Counter Brush
                IV) Putty knife
                V) Dust Pan
                VI) Waste receptacle

B. STEPS FOR CLEANING :

I. Proceed to work areas with all materials to Dryer room. 
II. Do hand dusting in following sequence with clean lint free dusters :

i) (a) Ceiling alongwith frames of lights, filters. 
       (b) Diffuser of Dryer room should be removed and should thoroughly be dedusted.

ii) Use another separate duster for walls of the Dryer. 
Shake cloths carefully into trash bag to remove soil.
                      Repeat Step 2 for Filling room, Air lock room and changing rooms.
Finally dedust the machine and cover of Laminar flow hood with clean lint free duster.

C. DUST MOPPING OF FLOORS:

With the sequence of Dryer room, Filling room, Air lock and changing rooms.  

1. Dust mop the floor unobstructed areas by walking forward. 
Keep mop head flat on floor and use push stroke and do not lift mop from floor. 
(Use counters brush to get soil out of corners).
2. Do not push large piles of dirt for long distances but leave in 
small piles to be picked up later.
3. Remove foreign materrs if any, with the help of puty knife.
Stroke knife slowly to prevent gouging floor.
4. Pick up soil with counter brush and dust pan.
5. Clean dust mop using a vacuum cleaner.

D. VACUUM CLEANING : 

Clean all ceiling of the area, walls, doors, machine and floors to remove the layer of dust from the surfaces.

PART – II :  WET MOPPING
      OF FLOOR  :
1. Sweep entire area to be mopped and remove any spills or sticky matter from floor.
2. Wash the entire floor and walls hot water.
3. Prepare cleaning solution :
i) Teepol = 200 gm
ii) Dettol = 250 ml
iii) Hot water = 10 liters.
4. Put on rubber shoes or slippers.
5. Soak MOP in cleaning solution, then pressure mop slightly in wringer.
6. Wipe corners by hand, using MOP stands.
7. Turn MOP over every 4 or 5 strokes to distribute solution.
8. Change the cleaning solution often.
9. Use clean water and mop to remove any remaining solution.
10. After wet mopping, dry the area with the help of vacuum cleaners having new bag.
11. After complete drying of the floor, apply sealer on the floor and WAX it to give final touch and hand over the area to prodcution department.

BY STERILE AREA STAFF

This procedure is applicable after completion of dust/wet Mopping of Area by sanitation department.
1. Shift all the isolated machine parts into filling room after dust/wet mopping with dusters and hot water followed by mopping with 5% phenol solution as per SOP No. 4 – A ,

2. Shift other accessories i.e. S.S. racks, tables, benches, decontaminator, Balances S.S tanks etc; after mopping with 5% phenol solution as per SOP No. 22.

3. Remove all the covers/seals of machine, sterlizers, pipes and filters.

4. Clean and wash the vacuum pipe (internally/externally) and air pipes (externally) with hot distilled water and mop with 5% phenol solution.

5. MOP the entire area and equipments as per SOP No. 4-A i.e. after maintenance work).