1.0 Purpose
1.1 To define a standard procedure for operation, proper cleaning and appropriate use of Double Cone Blender.
2.0 Scope
2.1 This Sop is applicable for Double Cone
Blender 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 log book.
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 Portable / Tap water
5.3 Purified Water
5.4 Nylon scrubber
5.5 Clean lint free cloth
5.6 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.
5.7 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 switch board etc with poly bag before cleaning.
6.4 Never spray water into the 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
the machine physically and check electric connection.
7.1.4 Turn
‘ON’ the electrical main breaker.
7.1.5 Rotate
the machine breaker black switch ‘ON” position, switch position right side of
the panel board.
7.1.6 Push
the Blender ‘ON’ green switch.
7.1.7 After
completion of blending time, then push the Blender ‘OFF’ red switch.
7.1.8 After
completion of discharging of powder.
7.1.9 After
completion of blending, rotate the machine breaker black switch ‘OFF” position
7.1.10 Finally
switching OFF the main breaker.
7.1.11 Record
the operating activity in Machine Logbook (Annexure-I)
and affix
‘To be cleaned’ label on the equipment.
7.2
Cleaning
7.2.1 Product to product cleaning (Type-A cleaning)
7.2.1.1 Remove previous status label.
7.2.1.2 Put “OFF” the electrical supply.
7.2.1.3 Affix “UNDER CLEANED- DO NOT USED “label on the equipment.
7.2.1.4 Remove residue of previous batch / product from the surrounding area of the machine.
7.2.1.5 Open the lid and remove the rubber gasket from it.
7.2.1.6 Clean the Blender, lid and rubber gasket using dry cotton cloth and nylon scrubber with detergent solution.
7.2.1.7 Finally rinse with purified water.
7.2.1.8 Wipe with moistened cloth 2-3 times to remove dust.
7.2.1.9 Wipe with dry clean cotton cloth to remove adhered water.
7.2.1.10 Wipe the blender, lid and gasket using dry clean cotton cloth to remove any adhered water.
7.2.1.11 Finally wipes the blender and lid with Isopropyl alcohol (70%) and allow drying in air.
7.2.2
Batch to Batch Cleaning (Type-B Cleaning)
7.2.2.1 Remove previous status label.
7.2.2.2 Remove residue of previous batch from the surrounding area
of the machine.
7.2.2.3 Clean the external part of the Double Cone Blender with the
help of 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.
8.0
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.
