Replacement of Activated Charcoal and Cartridges Oil Filter of N2 Plant
1.0 OBJECTIVE :
1.1 To lay down a procedure for Replacement of Activated Charcoal and Cartridge oil filter of N2 Plant.
2.0. SCOPE :
2.1 This procedure is applicable for replacement of Activated Charcoal and Cartridge Oil filter of N2 Plant situated at Pharma Dekho.
3.0. RESPONSIBILITY :
3.1 Operator Engineering Department shall be responsible for replacement of Activated Charcoal and Cartridge Oil filter and maintain the record.
3.2 Officer/Executive Engineering Department shall be responsible for to verify the replacement of Activated Charcoal and Cartridge oil filter and to take corrective action if any operational deviation.
4.0. ACCOUNTABILITY :
4.1 Head Engineering Department shall be accountable for compliance of SOP.
5.0. PROCEDURE :
5.1 PRIMARY CHECKS:
5.1.1. Ensure that the availability of new Activated Charcoal & cartridge oil filter.
5.1.2. Ensure that the Nitrogen plant should be switched ‘Off’.
5.1.3. Display the ‘Under Maintenance Board’ on N2 Plant.
5.2. PROCEDURE FOR REPLACMENT OF ACTIVATED CHARCOAL:
5.2.1 Open the Activated Charcoal filter vessel top cover & drain cover.
5.2.2 Take out the old Activated Charcoal from the vessel into the poly bag & keep it to designated place.
5.2.3 Clean the vessel from inside with fresh water properly. After cleaning of vessel, close the drain cover.
5.2.4 Take the new Activated Charcoal in a plastic container and clean it to with fresh water.
5.2.5 Load the cleaned Activated Charcoal in to the vessel.
5.2.6 Fit the vessel top cover & remove the under maintenance status board.
5.2.7 Start the N2 plant as per the current version of . SOP No.
5.2.8 Frequency of replacement of Activated charcoal once in eighteen months.
5.2.9 Fill the replacement record of Activated Charcoal in Annex –I.
5.3. PROCEDURE FOR REPLACMENT OF CARTRIDGE OIL FILTER:
5.3.1 Frequency for replacement of cartridge oil filter as mentioned below
| Sr. No. | Area / System | Filter ID No. | Filter Rating
(in micron) |
Frequency for replacement |
| 1 | Nitrogen Plant | NF-01 | 0.1µ | 08 month |
| 2 | Nitrogen Plant | NF-02 | 0.01µ | 08 month |
| 3 | Nitrogen Plant | NF-03 | 0.01µ | 08 month |
| 4 | Nitrogen Line | NF-04 | 0.1µ | 08 month |
| 5 | Nitrogen Line | NF-05 | 0.01µ | 08 month |
5.3.2 Fill the record of replacement of Cartridge Filter replacement in Annex-II
6.0. ABBREVIATION :
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1. | SOP | Standard operating procedure |
| 2. | EM | Engineering and maintenance |
| 3 | N2 | Nitrogen |
7.0 ATTACHMENTS (ANNEXES) :
Annex-I: Replacement record of Activated Charcoal.
Annex-II: Replacement record of cartridges oil filter.
8.0. REFERENCE :
In House
Annex-I: Replacement record of Activated Charcoal.
Annex-II: Replacement record of cartridges oil filter.
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Cleaning of Air Handling Unit Ducting
sop for Uninterrupted Power Supply UPS
sop for Operation of Chiller and Pumps
sop for Preventive Maintenance of Equipments and Machineries
sop for cleaning of Dosing tank
Replacement of Activated Charcoal and Cartridges Oil Filter of N2 Plant