1.0 Purpose
1.1 To define a standard procedure for operation, proper cleaning and appropriate use of Multi mill.
2.0
Scope
2.1 This Sop is applicable for Multi mill 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 Principle of Multi mill: The principle involves a variable force rotate blades having both knife and sharp edges with validated screen size to reduce particle in a controlled manner. The mechanism involve pulverization process (pulverization is grinding and crushing of materials into small particles) knife is used to cut the large particles into small size particle; these big particles are made from granules during the drying process in FBD. The hummer process is used to break the large particles into small sizes.
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 use mask, hand gloves and goggle's during operation.
6.2 Check the electric connection before operation.
6.3 Cover the electric switch board and motor with poly bag during cleaning.
7.0 Procedure
7.1 Operation
7.1.1 Production person shall ensure the cleanliness of the machine.
7.1.2 Before starting the operation production person get the line clearance from QA person and affix the status label with Product Name, batch details to equipment.
7.1.3 Fix the beater assembly.
7.1.4 Fit the screen of required size, chute and the hopper properly.
7.1.5 Before start operation, move the blade one rotation manually to check that no friction to the screen.
7.1.6 Place plastic drum with poly bag placed under the discharge chute.
7.1.7 Plug the main power of the machine.
7.1.8 Put “On” to start the operation.
7.1.9 Control the flow with stopper plate & ensure that the hopper is not charged heavily otherwise the Multi mill can get blocked.
7.1.10 Put “OFF” the machine after completion of the crushing.
7.1.11 Unplug the main power of the machine.
7.1.12 Affix “To Be Cleaned” label on Multi mill & fill the “Machine Logbook”. (Annexure-I)
7.2 Cleaning
7.2.1 Put “OFF” the electrical supply and cover the panel board with polythene bag.
7.2.2 Wipe off powder from Multi mill with dry clean lint free duster so that no residue of previous product present.
7.2.3 Disassemble the hopper, loading chute and screen and take it in washing room.
7.2.4 Wetting the blade, hopper, chute and screen with tap water.
7.2.5 Rubbing the blade, inner & outside of the housing, gasket, hopper, chute and screen with lint free cloth and hand brush and soaked in 0.4% Sodium Lauryl Sulphate solution.
7.2.6 Wash the blade, hopper, chute, screen and body of the machine with tap water. Finally rinse the blade, hopper, chute and screen with purified water.
7.2.7 Wipe the blade, hopper, chute, screen and body of the machine with clean lint free cloth soaked in 70 % IPA (Isopropyl Alcohol) to remove surface water.
7.2.8 Machine operator / worker will request Production Officer and QA Officer for checking visual inspection.
7.2.9 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.
7.2.10 Record in Machine logbook and affix the label of “Cleaned” in the machine.
7.2.11 After cleaning the machine if it remains without operation for next 72 hour, will undergo Re-cleaning operation.
8.0
Reference
Document
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.
