sop for area and equipment clearance procedure

 

OBJECTIVE: 
1.0 To describe the procedure for checking of equipment and area before giving line clearance during manufacturing and packaging operation.

2.0 RESPONSIBILITIES:

2.1 Quality Assurance – Officer/ Executive shall be:
2.1.1 Responsible for assuring the equipment and area for free from remnant of previous batch / product at manufacturing and packaging area.
2.1.2 Responsible for checking cleanliness of area and equipment.
2.1.3 Responsible to inform to Head of Department Production in case of any abnormality is observed.
2.1.4 Responsible for checking the compliance after rectification of abnormality.

3.0 ACCOUNTABILITY:

Head – Quality Assurance

4.0 PROCEDURE:



4.1 Manufacturing Area:
4.1.1 On receipt of intimation for equipment & line clearance from production follow the following checks.
4.1.2 Ensure that relevant BMR is completed up to the previous stage.
4.1.3 Check that status board is displayed with all the batch details and information about the stage.
4.1.4 Ensure that area and equipments are free from raw material, blends, granules, tablets, capsule, bottles, vials, seals, rubber stoppers, inners caps, labels, poly-bags, S.S. container of previous manufactured product.
4.1.5 Raw material, blend, granules, tablets, coating solution, capsule, vials, rubber stoppers, seals, bottles, inner cap of previously manufactured product are transferred to next manufacturing /quarantine/removed.

4.1.6 The printout technology parameter of previous manufactured product were removed.
4.1.7 Check the cleanliness of the machines. Incase of ‘A’ type cleaning, check the cleanliness of the machine visually. If cleanliness is satisfactory, then sign on ‘A’ type-cleaning checklist. In case of ‘B’ type cleaning, ensure that rinse water of all equipment are get cleaned from QC and sign on ‘B’ type checklist.
4.1.8 Ensure that status tag of machine is affixed stage label with all batch detail and stage.
4.1.9 Ensure for cleaning of other accessories like S.S. table, S.S. Container, S.S. pallets, scoops, tools, weighing balances etc.
4.1.10 Check that waste bin is cleared and cleaned.
4.1.11 Ensure that temperature and humidity of area / room is within the limit mentioned in BMR.
4.1.12 Ensure that the differential pressure of area is under the specified limit mentioned on magnehelic gauge.
4.1.13 Ensure for cleanliness of wall, roof, floor, return grill, area under machine, equipment.
4.1.14 Ensure the cleanliness of all utility pendants.
4.1.15 Check the record for cleaning, Relative Humidity & Temperature, Differential air pressure of room, equipment logbook are filled by production before giving line clearance.
4.1.16 Check that status board is displayed with all the batch details and information about the stage.
4.1.17 Ensure that microbial and water analysis result of area are within limit.
4.1.18 Fill equipment and clearance checks list while giving the line clearance. If all above checks are found satisfactory, then sign in line clearance of BMR.
4.1.19 Refer annexure –2 for equipment and area line clearance check list for different areas.

4.2 Packaging area (Stripping / Blistering of Tablets & Capsule):



4.2.1 Ensure that status label is displayed with all the batch details and stage.
4.2.2 Ensure the area and equipments are free from tablets, capsules, foils, stereos, labels, poly-bags, of previous batch / product.
4.2.3 Check the cleanliness of equipment of blister / strip / sealing machines, inspection table, de-foiling machine, incase of batch change over.
4.2.4 Incase of product change over, check that cleaning is done as per ‘B’ type cleaning. And ensure that rinse water analysis are get cleaned from QC.
4.2.5 Ensure that temperature and humidity of room is within the limit mentioned in BMR.

4.2.6 Ensure that the differential pressure of area is under the specified limit mentioned on magnehelic gauge.
4.2.7 Ensure that all utilities pendant are cleaned.
4.2.8 Ensure cleanliness of wall, return riser, floor etc.
4.2.9 Checks the record for cleaning, Relative Humidity & Temperature, Differential air pressure of room, equipment log book are filled by production before giving line clearance
4.2.10 Fill equipment and clearance checks list while giving the line clearence. If all above checks are found satisfactory, then sign in line clearance of BMR.
4.2.11 Refer annexure –2 for equipment and area line clearance check list for different areas.

4.3 Packaging area (Labeling & Packaging)

4.3.1 Check the following equipment for cleanliness and pressure remnants of previous products / batch which includes label, carton, leaflet, vial, bottle, sterile W.F.I. tablet, capsule, labels, poly-bags of previous products / batch on receipt of intimation of line clearance from production.
a. Turn table
b. Labeling machine
c. Packaging belt
d. Auto cartonator
e. Auto shrink wrapping
f. Packaging belt and surrounding.
4.3.2 Ensure that coding stereo of previous batch / product is removed
4.3.3 Ensure the cleanliness of the area
4.3.4 Ensure that waste bin cleared and cleaned.
4.3.5 Ensure that the details of packing operation are indicated on the display board.
4.3.6 Ensure the relevant BMR is duly completed up to last operational stage.
4.3.7 Fill equipment and clearance checks list while giving the line clearance. If all checks are found satisfactory, then sign in line clearance of BMR.
4.3.8 Refer annexure –2 for equipment and area line clearance check list for different areas.
4.4 Off Line Over printing
4.4.1 Ensure that coding stereo of previous batch / product is removed
4.4.2 Ensure that over printed packing material of previous batch/product is removed from room.
4.4.3 Ensure that rejected carton , labels are removed from room.
4.4.4 Ensure that waste bin cleared and cleaned.
4.4.5 Ensure that room & Equipment are free from remnants of previous batch/product.
4.4.6 Ensure the relevant BMR is duly completed up to last operational stage.
4.4.7 Ensure the cleanliness of the area.
4.4.8 Ensure that the details of printing operation are indicated on the display board
4.4.9 Ensure that machine logbook is filled.
4.4.10 Reconciliation of over printed packing material of previous batch/product is completed.
4.4.11 Fill equipment and clearance checks list while giving the line clearance. If all checks are found satisfactory, then sign in line clearance of BMR.
4.4.12 Refer annexure –2 for equipment and area line clearance check list for different areas.
5.0 REASON FOR REVISION:

This SOP is modified in order to incorporate Area & Equipment Clearance Check List.



6.0 TRAINING:
Trainer — Head – Quality Assurance
Trainee — Quality Assurance Officers
Period — One day
7.0 DISTRIBUTION:

Certified Copy No.1 : Head – Plant Operations

Original Copy : Head – QUALITY ASSURANCE

8.0 ANNEXURE:

Annexure – 1 : Schematic Diagram
Annexure – 2 : Area & Equipment Clearance Check Lists

9.0 REFERENCE:

In-house

ANNEXURE – 1

 

SCHEMATIC DIAGRAM

 

ANNEXURE – 2

FORMAT FOR EQUIPMENT & AREA CLEARANCE CHECK LIST

Equipment & Area Clearance Check List

Previous Product  :  ___________________________      Batch No:________________

Next Product         :   _________________________                    Batch No:________________

 

Area		Room No	Equipment & I.D.No
A	Granulation
B	Compression
C	Coating
D	Capsule Filling/Sealing/Inspection
E	Inspection
F	Blistering /Striping
G	Packaging
H	Over Printing

 

Sr	Checks
1	Equipment are free from raw material, granules, tablets, coating sol. , coated tablets ,capsules, labels, poly-bags ,S.S. Containers etc of previously manufactured product
2	Raw material, granules, tablets, coating sol. , coated tablets ,capsules, labels, poly-bags ,S.S. Containers etc of previously manufactured product are transferred to next manufacturing stage/ Quarantine.
3	Wall , floor, return grill , utility pendent , S.S. table, S.S. container, S.S. pallets , scoops, tools ,waste bin etc are cleaned.
4	Equipment are cleaned and cleaning check list are filled
5	Check that equipment logbooks are filled for previous batch/ product.
6	Remaining printed al. foil ,plane al. foil ,PVC. PDVC, of previous product are removed
7	Rejected foil ,blister ,strip ,tablets ,capsules of previous batch/product are removed
8	Incase product change over, rinse water of equipments are cleared.
9	Reading of temperature, humidity and room differential are within limit
10	Temperature, humidity and room differential air pressure records are filled
11	BMR is duly completed up to previous stages.
12	The cleaning status label presence is checked.
13	Packed finish goods of previous batch /product were removed
14	Rejected carton, label, catch box, show box, leaflet, tablet, strip, blister ,capsule , shipper  are removed from line
15	Complete conveyer belt and its bottom  is free from remnant of previous batch/product.
16	Shrink  wrapping machine is from remnant of previous product and clean.
17	All waste from waste bin were removed & waste bin is cleaned and new poly bag is placed in side.
18	Printed packing material   like carton, show box, label etc of previous batch were removed from room.
19	Stereos  of previous batch were removed.
20	Print machine is cleaned and status label is affixed
21	Reconciliation of over printed packing material of previous product/batch is completed
22	Log  book of printing machine is filled for previous batch/product.
Released / Not  Released
Checked by & Date