SOP For Installation Qualification of Encapsulation Machine

SOP For Installation Qualification of Encapsulation Machine

• PURPOSE
• To describe the Installation Qualification of Encapsulation Machine along with Tumble Dryer and Gravity Feed Pipes, its accessories and to define the Specification of the system in order to:

• ensure that the equipment meets the specification as Design Qualification
• aid verification of the installation as per equipment general arrangement
• ensure that the system installation meets acceptance criteria.
• ensure that the equipments will be installed in accordance with current Good manufacturing Practices.

• SCOPE
• The scope of this document applies to the installation qualification of Encapsulation Machine along with Tumble Dryer and Gravity Feed Pipes.

• RESPONSIBILITIES
  • It is the responsibility of the Manufacturer to perform all the specifications verification checks and tests with respect to installation qualification and compiling data in co-ordination with client.
  • It is the responsibility of the client to check and approve the installation qualification.

• PROCEDURE
• The following requirement / practices apply to, Encapsulation Machine along with Tumble Dryer and Gravity Feed Pipes Installation Qualification activities:

• Verify that systems are installed in accordance with approved engineering drawings and documents, which shall include the following
  • General arrangement drawing.
  • Installation specification; and
  • Equipment manuals
• Verify that the equipment and instrumentation are clearly described as per vendor, model, capacity, materials of construction and any critical criteria.
• Verify that major components are tagged or labelled with a unique ID number.

• INSTALLATION QUALIFICATION TESTS
• The table below lists the tests to be performed as part of the Installation Qualification phase.

TEST NUMBER	CRITICAL FEATURE
5.1	Documents & Drawings Verification
5.2	Verification of Technical Specification for In-House & sub-components / bought out items
5.3	Utilities Verification
5.4	Material of construction verification
5.5	Critical Instrument Calibration Verification

 

• Documents & Drawings Verification
  • Rationale – To verify that the documentation provides complete and correct technical references and permits servicing of the units.

• Test equipment – None Required.

• Procedure – Verify that the required documents and drawings listed in the Table 5.1.5 is available.

• Review the documents and drawings for completeness and Exactness with the installed units.
• Attach the copies of the drawings to this protocol or reference the location from where they can be easily retrieved.
• Any items in the installation, which are not conforming to the Corresponding drawings must be commented on in the appropriate space. List the non-conformances and the reasons for them in an attachment if necessary.

• Acceptance Criteria:
  • The documents must be accurate and complete.
  • The drawing information must correspond to the physical installation.

 

• Documentation Verification Results

Sr. No.	Description	Document No.	Verified By	Date
1	Installation, Maintenance and Operation Manual
2	General arrangement drawing

• Conclusions / Comments:

• Verification of Technical Specification for In-House & sub-components / Bought out items

• Purpose– To verify that each major component of the Encapsulation Machine (BCM-S6GPS) along with Tumble Dryer and Gravity Feed Pipes is present and identified.

• Test Equipment – None Required
• Procedure – Confirm that identification nameplates have been applied to the units and that these indicate the following (where applicable).
  • – Type
  • – Identification (Tag) No.
  • – Manufacturer
  • – Model Number
• Confirm that the various components of Encapsulation Machine along with Tumble Dryer and Gravity Feed Pipes is present and tagged as per specifications and drawings, in the proper number and configuration.
• Note any deviations or discrepancies and recommend follow Up action if required.

• Acceptance Criteria – All units and parts specified in design qualification and on Latest revision of drawings must be present, documented and tagged.

• Major Components Result

Description	Specification	Meets Spec. (Yes / No.)	Verification Source	Sign.	Date
Equipment Description
Make
Model	BCM–S6GPS
Sr. No.	BCM – 06040123
Dimension	1700 mm (W) X 1200 mm (L) X 1810 mm (H)
ID. No.	EQ/PR/234
MOC	Main Body : AL6061 Cover : STS 304
Electric Connection	Non-Flameproof
Power Rating	440 V / 50 Hz / 3Ph. / 8 KW
Compressed Air	5-6 Kg/cm2
2. Tumble Dryer
Dimension	1120 mm X 4000 mm X 1345 mm
MOC	Main Body : STS 304 Cover : STS 304
Power Rating	440 V / 50 Hz / 3Ph. / 2.4 KW
3. Main Motor
Make	Shin Myung
Type	3 Ph., 38 Type,
Power Rating	1.5 KW / 2 HP /  230-380 V / 50 Hz
Sr. No.	BK 227
Output RPM	150-180
Gear Ratio	10:1
4. Motor (Coolant Pump)
Make	Hansung
Type	3 Ph., 38 Type,
Power Rating	100 W / 50 Hz / 2 Pole
Model	HCP -100 S
Pipe size	318 B
Power Rating	220-230 V / 0.5-0.3 amp.
Insulation	E
Bearing	6201 / 620022
Sr. No.	041206
5.Medicine Transfer Pump
Make	Shin Myung electric Mfg.Co.Ltd.
Type	3 Ph. Induction Motor
Volts	220 / 380
HZ	50 / 60
KW /HP	0.21,1/4
RPM	75/90
Geared Ratio	20:1
Sr.No.	BK217
6. Motor for Cooling Drum (LHS)
Make	Shin Myung electric Mfg.Co.Ltd.
Sr.No.	BK225
KW / HP	0.21, 1/4
Volts	220/380
HZ	50 / 60
RPM	25 / 30
7. Motor for Cooling Drum (RHS)
Make	Shin Myung Electric mfg. co. Ltd.
Sr.No.	BK226
KW / HP	0.21, 1/4
Volts	220/380
HZ	50 / 60
RPM	25 / 30
8. Motors for Tumble Dryer
Make	Shin Myung electric Mfg.Co.Ltd.
KW ./ HP	0.2, 1/4
Volts	220/380
HZ	50 / 60
RPM	50 / 60
Geared Ratio	30:1
Qty.	06 nos.
Sr.No.	BK220,BK219,BK223,BK221,BK222,BK224
9. Motor for Mangle Roller
Make	Shin Myung electric Mfg.Co.Ltd.
KW / HP	0.2, 1/4
Volts	220/380
HZ	50 / 60
RPM	75 / 90
Sr.No.	BK218
8. Motor
Make	SPG Co.Ltd.
Model	S9140 GEL-T
Type	Single Phase induction geared motor
Volts	100-115
RPM	1300-1550
Qty.	04 nos.
Location	Medicine Stirrer, Conveyor Motor, Chute assembly, Stripper
9. Motor
Make	SPG Co.Ltd.
Model	S9140 GEL-T
Qty.	02 nos.
Type	Single Phase induction geared motor
Locations	Ribbon Lubrication (LHS)
Volts	100-115
RPM	1300-1550
10. Motor
Make	SPG Co.Ltd.
Model	S9140 GEL-T
Locations	Ribbon Lubrication (RHS)
Qty.	02 nos.
Type	Single Phase induction geared motor
Locations	Ribbon Lubrication (RHS)
Volts	100-115
RPM	1300-1550
11. FRL Unit
Make	Samin Corporation
11.1 Filters
F 3000 Filter	Range: 9.9 Kg/cm2 Max. Temp.: 600C
R 3000 Regulator	Range: 0.5–8.5 Kg/cm2 Max. Temp.: 600C Max. Pressure.:9.9Kg/cm2
L 3000 Lubricator	Range: 9.9 Kg/cm2 Max. Temp.: 600C

• Conclusions / Comments

• Utilities Verification
• Rationale – To verify that all necessary utilities are correctly installed.
• Procedure – Confirm that utilities connections are configured as per specification and in compliance with local codes.

• Record the results in the table below. Note any deviations or discrepancies.
• Acceptance Criteria – All services and connections must be installed and documented.

• Utilities Specification Results

Description	Specified	Observation	Initial / Date mm/dd/yy
Electrical connection	To be provided
Compressed Air connection	To be provided

• Conclusions / Comments:

• Material of Construction Verification
  • Rationale – To verify that all assembly of Encapsulation Machine along with Tumble Dryer and Gravity Feed Pipes has been manufactured as per the specification provided by the customer.

• Acceptance Criteria:
• All material of construction for the Encapsulation Machine along with Tumble Dryer and Gravity Feed Pipes shall meet the MOC provided in Design Qualification.
• All materials of construction are verified based on their material testing certificates provided by the Manufacturer.

• Material of Construction verification Results

Description	Specification	Meets Spec. (Yes/No)	Verification Source	Sign.	Date
1.0. Medicine Pump Assembly
Medicine Hopper	STS316L fibers and NBR Rubber and coated on both sides with PTFE.
Hopper cover	STS316L
Top plate	STD11
Slide valve	STD11
Plunger	STD11
Bank Plate	STS304
Pump block	STD11
Plunger seal	Teflon
2.0. Die Roll Assembly
Die roll shaft yoke	S45C
Pressure bar	S45C
Knob	S45C
Die roll	AL7075
Gelatin ribbon guide roller	S45C & Teflon coating
Cover	STS304
3.0       Shut-off valve assembly
Pin	S45C
Wedge	SW45C
Distribution Plate	S45C
Valve bottom plate	S45C
Valve side plate	S45C
Side valve	S45C
4.0. Spreader boxes
Spreader box	SM45C
Flow control sleeve	STS304
Float	STS304
Gate	SM45C
5.0. Cooling drum assembly
Ribbon cooling drum	TP304
6.0. Tumble Roller Assembly
Flange	MC nylon
Support	SUS304
Wire Mash	SUS304
7.0. Mangle rollers and stripper conveyor assembly
Stripper Conveyor belt	STS304
Mangle Roller Body	SS41
Front Plate	SS41
Stripper Conveyor body	SS41
Capsule transfer Conveyor belt	STS304
Conveyor body	AL5061
Bracket assembly	SS41
Stripper roller	SS41
8.0. Lubrication roller assembly
Oil roller shaft	STS304
Cover	STS304
Support	S45C
Trimming roller	AL 5040 & Teflon coating
Oil roller support plate	S45C
9.0. Lubrication system assembly
Gelatin ribbon oil tank	STS304
Medicine pump oil tank	STS304
Die roll housing oil tank	STS304
Bank block	BRASS
Piston block	S45C
Cam housing	S45C
Control bolt	S45C
Cam shaft	S45C
10.0. Gravity Feed Pipes
Gravity feed pipes	Non-Toxic Food Grade Silicon Pipes

• Conclusions / Comments:

• Critical Instrument Calibration Verification

• Rationale – To verify that all critical instruments for the Encapsulation Machine along with Tumble Dryer and Gravity Feed Pipes has been calibrated before starting the Operational Qualification.

• Procedure:
  • Verify that all critical instruments are calibrated using an approved procedure, against a traceable standard.
  • Note any deviations or discrepancies and recommend follow up actions if required.
  • For all critical instruments, attach copies of calibration certificates to this protocol.

• Acceptance Criteria – All critical instrumentation for the Encapsulation Machine along with Tumble Dryer and Gravity Feed Pipes shall be in a state of calibration.

• Instrumentation List Results

Description	specification	Meets Spec. (Yes / No.)	Verification Source	Sign.	Date
1.0. Pressure Gauge
Make	CKD
Range	0-10 Kgf/cm2
Least Count	0.5 Kgf/cm2
Model	G-59D-8-PK10
Location	Die Roll
Calibration Status	Calibration Certificate
2.0. Pressure Gauge
Make	Hisco
Range	0-2 Kgf/cm2
Least Count	0.1 Kgf/cm2
Location	Main Lubrication oil for ribbon
Calibration Status	Calibration Certificate
3.0. Weight Gauge Plunger Type
Make	Peacock
Range	0-10 mm
Least Count	0.01 mm
Location	Housing
Calibration Status	Calibration Certificate
4.0. Plunger Type Dial Gauge
Make	Peacock
Range	0-10 mm
Least Count	0.01 mm
Location	Spreader Box (RHS)
Calibration Status	Calibration Certificate
5.0. Plunger Type Dial Gauge
Make	Peacock
Range	0-10 mm
Least Count	0.01 mm
Location	Spreader Box (LHS)
Calibration Status	Calibration Certificate
6.0. Pressure Gauge
Make	CKD
Range	0-10 Kgf/cm2
Least Count	0.5 Kgf/cm2
Model	G-490-6-PK10
Location	LHS lubrication oil for ribbon
Calibration Status	Calibration Certificate
7.0. Plunger Type Dial Gauge
Make	Peacock
Range	0-10 mm
Least Count	0.01 mm
Location	Spreader Box (RHS)
Calibration Status	Calibration Certificate
8.0. Plunger Type Dial Gauge
Make	Peacock
Range	0-10 mm
Least Count	0.01 mm
Location	Spreader Box (LHS)
Calibration Status	Calibration Certificate
9.0. Plunger Type Dial Gauge
Make	Peacock
Range	0-10 mm
Least Count	0.01 mm
Location	Ribbon Thickness gauge
Calibration Status	Calibration Certificate
10.0. Temp. Sensor
Range	0-75 0C
Least Count	0.1  0C
Location	segment
11.0. Temp. Sensor
Range	0-75 0C
Least Count	0.1 0C
Location	Hopper
Calibration Status	Calibration Certificate
12.0. Temp. Sensor
Range	0-75 0C
Least Count	0.1 0C
Location	Spreader Box (RHS)
Calibration Status	Calibration Certificate
13.0. Temp. Sensor
Range	0-75 0C
Least Count	0.1 0C
Location	Spreader Box (LHS)
Calibration Status	Calibration Certificate
14.0. Temp. Sensors
Range	0-75 0C
Least Count	0.1 0C
Location	Gelatin feed pipes
Qty.	02No’s
Calibration Status	Calibration Certificate
15.0. Temp. Sensors
Range	0-30 0C
Least Count	0.1 0C
Location	Coolant
Calibration Status	Calibration Certificate

• Conclusions / Comments:
• Installation Qualification Tests Status.
• The table below lists the tests performed and related results

Test  Number	Critical Feature	Pass	Fail	Deviation Found
				Yes	No
5.1	Documents & Drawings Verification
5.2	Verification of Technical Specification for In-House & Sub-contract / bought out items.
5.3	Utilities Verification
5.4	Material of Construction Verification
5.5	Critical Instrument Calibration Verification

 

 

• Data Analysis, Summary of IQ & Recommendations

 

• AMENDMENT RECORD

Sr. No.	Item Name	Remarks	Signature and Date

• Note: Any changes made in the system must be recorded in this sheet.

 

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