1.0 Purpose
1.1 To define a standard procedure for operation, proper cleaning and appropriate use of Fluid Bed Dryer.
2.0
Scope
2.1 This Sop is applicable for Fluid Bed
Dryer of tablet manufacturing area at “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1 Only concern operator is responsible for normal operation. He/ She inform the supervisor about any deviation from normal operation. He also maintains logbook.
3.2 Sr. Officer-
Production/Officer- Production is responsible for monitoring day to day
activity.
3.3 Production Officer and Quality
Assurance Officer should ensure that the procedure is implemented properly.
4.0 Abbreviations and Definitions
4.1 BMR :Batch Manufacturing Record
5.0 Materials and Equipment
5.1 Poly bag
5.2 Hose pipe
5.3 Portable / Tap water
5.4 Purified Water
5.5 Hand brush
5.6 Nylon scrubber
5.7 Clean lint free cloth
5.8 Detergent Solution: 0.4% (w/v) Sodium Lauryl Sulphate solution ; 4 gm Sodium lauryl Sulphate is dissolved in 1.0 liter of portable / tap water to prepare detergent solution.
5.9 Disinfectant Solution: 70 % Isopropyl Alcohol.
6.0 Precaution / Health and Safety Considerations
6.1 Don’t press electric switch with wet hand.
6.2 Check the electric connection before operation.
6.3 Cover the control panel; switch board etc. with poly bag before cleaning.
6.4 Never spray water into the control panel, switch board.
7.0 Procedure
7.1 Operation
7.1.1 Before
starting operation, the operators and the production personnel with this
operation must ensure that the room is properly cleaned and all materials of
previous product are removed.
7.1.2 Production
person get the line clearance from QA person and affix the status label with Product Name, batch details to
equipment.
7.1.3 Check
that both dampers are open during operation.
7.1.4 Check
that pneumatic system is working properly and set the dry finger bag.
7.1.5 Set
the loaded bowl properly with Platform.
7.1.6 “ON”
main switch.
7.1.7 Set
timer and temperature.
7.1.8 “ON”
blower switch and then heater switch.
7.1.9 After
drying stop the heater switch remaining the blower switch ON. After 5 minutes
stop the blower switch.
7.1.10 Affix
‘To be cleaned’ label on the equipment after completion of the operation.
7.2
Cleaning
7.2.1 Product to product Cleaning
7.2.1.1 Put “OFF” the electrical supply.
7.2.1.2 Cover all the electrical parts with poly bags.
7.2.1.3 Wipe off all residual powder from FBD chamber with the help of dry clean lint free cloth followed by wet cloth.
7.2.1.4 Remove the finger bag from ring. Then clean the ring with potable water followed and then again with potable water, finely rinse with sufficient amount of Purified water.
7.2.1.5 Follow the respective SOP for cleaning the finger bag .
7.2.1.6 Wipe off all residual powder from FBD bowl and rinse with potable water.
7.2.1.7 Rub the lower surface sieve and inner surface of the container with brush soaked in 0.4% Sodium Lauryl Sulphate water solution.
7.2.1.8 Wash the container and sieve with tap / portable water.
7.2.1.9 Finally rinse with purified water.
7.2.1.10 Wipe the surface of the container with dry lint free cloth to remove the water.
7.2.1.11 Dry the container and sieve with compressed air to remove the deposited water in the different junction.
7.2.1.12 Wipe the surface of the container and sieve with lint free cloth soaked in 70% IPA (Isopropyl Alcohol) thus surface water evaporates quickly.
7.2.2 Batch to Batch cleaning
7.2.2.1 Remove previous status label and dispose of by tearing.
7.2.2.2 Remove residue of previous batch / product from the
surrounding area of the machine.
7.2.2.3 Clean the external part of machine with vacuum cleaner and
cloth.
7.2.3 Machine operator / worker will request Production Officer and QA Officer for checking visual inspection.
7.2.4 At first Production Officer will check the machine and its surroundings, then QA Officer will check the machine and its surroundings. If it found satisfactory result, then he / she will issue “Cleaned” label.
7.2.5 Record in Machine Logbook (Annexure-I) and affix the label of “Cleaned” in the machine.
7.2.6 After cleaning the machine if it remains without operation for next 72 hour, will undergo Re-cleaning operation.
8.1 In-house
9.0
Annexure
9.1 Annexure-I : Format of ‘Machine Logbook’
10.0
Revision
History
|
Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
11.0
Training
11.1 Head of Production or his nominee give
the training of production operator and worker.
Annexure-I : Format of ‘Machine Logbook
