IQ of Blister Packing Machine (BQS)

TABLE OF CONTENT

  • Purpose
  • Scope
  • Responsibilities
  • Procedure
  • Installation Qualification tests
  • Documents & Drawings Verification
  • Verification of Technical Specification for In-House & sub-components / Bought out items
  • Utilities Verification
  • Material of Construction Verification
  • Critical Instrument Calibration Verification
  • Installation Qualification Tests Status
  • Data Analysis, Summary of IQ & Recommendations
  • Amendment Record
  • Conclusion
  • PURPOSE

To describe the Installation Qualification procedure to be used during qualification of Blister Packing Machine (BQS), 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 drawing
  • Ensure that the system installation meets acceptance criteria
  • Ensure that the equipment will be installed in accordance with Good manufacturing Practices.
  • SCOPE

This procedure applies to the installation qualification of Blister Packing Machine (BQS) and its accessories to be installed.

  • RESPONSIBILITIES
    • It is the responsibility of the Manufacturer to prepare the installation qualification protocol as per Design Qualification
    • It is the responsibility of the client to check and approve the installation qualification protocol.
    • 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.
  • PROCEDURE

The following requirement / practices apply to PAM-PAC Blister Packing Machine  (BQS), 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
Documents & Drawings Verification
Verification of Technical Specification for

In-House & sub-components / bought out items

Utilities Verification
Material of construction verification
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 as per below table.
    • 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.
S.No Description Document No Verified By Date
1 Installation, Operation and Maintenance Manual
2 General arrangement drawing
  • Verification of Technical Specification for In-House & sub-components / Bought out items 
  • Purpose

To verify that each major component of the PAM-PAC Blister Packing Machine  (BQS), 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)
  • Manufacturer
  • Model Number
    • Confirm that the various components of PAM-PAC Blister Packing Machine (BQS), 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.

  • Components Result
Description Specification Meets

Spec. (Yes/No)

Verification Source Initials Date
1.                  Blister Packing Machine
Model  BQS
Type Thermoforming Blister Packing Machine
Dimension 4500L X 1900W X 2000H
Output 45 Cycles/min. for PVC/ALU forming

35 Cycles/min. for ALU/ALU forming 200 cycles / min. in punching station.

Forming area 240 x 180 mm

Max. Draw depth 12 mm

Max. Draw of Length 180 mm.

Max. Roll Diameter (Forming Film) 450 mm x 252 mm width

74 – 76 mm core dia.

Max. Roll Diameter (Lidding Foil) 250 mm x 246 mm width

74 – 76 mm core dia.

Part A = Bought out items
2.                  Heating plate bottom
Plate Dimension 265 x 368 mm
Treatment Teflon coating
Thermocouple To be provided
Heater type Embedded type
Location Heating station
3.                  Pneumatic  Cylinder
Make Festo
Model ADVUP-40-P-A-25Z1-30Z2
P max 10 bar
Location Bottom  Heating Plate
4.                  Heating plate top
Plate Dimension 265 x 368 mm
Treatment Teflon coating
Thermocouple To be provided
Heater type Embedded type
Location Heating station
5.                  Pneumatic  Cylinder
Make Festo
Model ADVC – 32- 25 – I-P-A

188206T108

P max 10 bar
Location Top Heating Plate
6.                  Flow switch
Make IFM
Model SI1000

SID10ADBF PKG/US

7.                  Top plate
Plate Dimension 235 x 181 mm
Location Forming station
8.                  Water Condensation Valve
Make Saimag
Type Diaphragm
Model DT-04
Size 1½”
9.                  Bottom plate
Plate Dimension 235 x 181 mm
Location Forming station
10.              Hopper
MOC Stainless Steel 316
View Glass To be provided
Capacity 50 Ltrs.
Location Feeding
11.              Level Sensor
Type Proximity
Location Rotary Vibrator
Make IFM
Rating 250 ma, 36 V DC
12.              Linear vibrator
MOC Stainless Steel 316
Location Feeding
13.              Distributor plate
MOC Stainless Steel 316
Location Feeding
14.              Top plate
Plate Dimension 185 x 255 mm
Thermocouple To be provided
Location Sealing station
15.              Pneumatic Cylinder
Make Festo
Model ADVC-40-25-I-P-A

188236T108

Pmax 10 bar
Location Top sealing plate
16.              Locking Cylinder
Qty. 02 Nos.
Make Festo
Model ADVU-25-50-A-P-A

156615T123

Pmax 10 bar
Location Top sealing plate
17.              Bottom plate
Plate Dimension 280 x 178 mm
Location Sealing station
18.              Exhaust Fan
Model REC22038 AL
Power Rating 220 V, 50 Hz, 1 Amp.
Make Rexnord
Location Sealing Station
19.              Emergency Switch
Location Punching and Perforation
20.              Hydraulic Cylinder
Sr.No.
Type FFCB4
Pmax 160 kg / cm2
Make Indian pneumatic and hydraulic co.
Location Bottom Sealing Plate
21.              Bracket
Material LM 16
Hardness 90-100 BHN
Treatment GBB
Quantity 1 No.
Location Cooling station
22.              Top Plate
Material H9 T6
Treatment GBB
Quantity 1.No.
Location Cooling station
23.              Bottom Plate
Material H9 T6
Treatment GBB
Quantity 1 No.
Location Cooling station
24.              Pneumatic cylinder
Make Festo
Model ADVU-63-5-P-A

156007T123

Pmax 10 bar
Location Bottom cooling plate
25.              Door limit Switches
Qty. 06 Nos.
Model XCJ-110
Make Telemecanique
Rating 10 A, 240 V AC
Location Heating station / Forming station / Sealing station / Cooling station / Perforation and punching station / Material pickup
26.              Pulling disc (Front)
Material HCHCr
Hardness 45-50 HRC
Treatment Blackodising
Location Pulling station
27.              Pulling disc (Rear)
Material HCHCr
Hardness 45-50 HRC
Treatment Blackodising
Location Pulling station
28.              Cutting plate (Part of change part )
Material HCHCr
Hardness 58-60 HRC
Treatment Blackodising
Location Cutting station
29.              Punch  (Part of change part )
Material HCHCr
Hardness 58-60 HRC
Treatment Blackodising
Location Cutting station
30.              Good bad sorting chute
MOC Stainless Steel 304
Location Blister sorting station
31.              Suction wheel
Material Nylon
Location Blister pick up station

 

Description Specification Meets

Spec. (Yes/No)

Verification Source Initials Date
Part B = Bought out items
1.                  PVC Unwinding motor
Make Technocraft
Rating 0.15 HP
RPM 1400 RPM
Voltage 415 V
Phase 3 phase
Location PVC Unwinding station
2.                  Limit Switch
Make Telemacanique
Model XCJ-127
Rating 10A 240V AC
Location Near PVC unwinder
3.                  Rubber ring
Material Silicon Rubber
Size 50 X 5
Location PVC Unwinding station
4.                  Joint detection sensor
Make Data Logic sensor
Model TL U11
Location Splicing station
5.                  Sensor for dancing lever
Type Inductive
Quantity 04
Model EGT12X02APO2

45000L

Make Tekeniceuchner
Location  PVC unwinding station (02 Nos.) Aluminium Foil unwinding station. (02 Nos.)
6.                  Heating Coil
Make Saket
Rating 2.5 KW
Location Heating station
Description Specification Meets

Spec. (Yes/No)

Verification Source Initials Date
7.                  Power Pack
 Make Zeon
Working pressure 160 Bar
8.                  Power Pack motor
Type 3 Phase induction
make Crompton Greaves
Motor Rating 5 HP
Sr. No.
Voltage 415 V AC
RPM 1430 RPM
Location Heating Station
9.                  Vibrator controller (Linear)
Make Sai control
Voltage 230 V
Rating 3 A
Location Control Panel
10.              Vibrator controller (Rotary)
Make Sai control
Voltage 230 V
Rating 3 A
Location Control Panel
11.              Servo motor
Make B & R Automation
Rating In 0.70A

Mn 0.6 Nm

Io  0.73A

Mo 0.6 Nm

Sr. No.
Location Drum feeder
12.              Motor for Al. Unwinding
Make Bharat Bijlee
Rating 0.25 HP
RPM 1350 RPM
Description Specification Meets

Spec. (Yes/No)

Verification Source Initials Date
Voltage 415 V AC
Phase 3 Phase
Location Al. Unwinding station
13.              Proximity Switch
Qty. 05 Nos.
Make Tekniceuchener
Model EGT 18 X 05 AP024-5000 L
Location Near Al. Unwinding Station / Perforation and punching / Drum feeder / Servo main motor / Pickup station
14.              Proximity Switch
Qty. 02 Nos.
Make Telco
Model SMP8500PG2.5
Location Blister Discharge
15.              Air Gun
Make Festo
Model LBP – ¼

3552858

Pmax 10 bar
16.              Ink cartridge
Make Process instrumentation and control
Size Dia.50 X 245 Lg.
location Overprinting Station
Description Specification Meets

Spec. (Yes/No)

Verification Source Initials Date
17.              Ink
Make Dolphin Ink (I)
Specification DIPL 39
Mixture 60% with thinner
location Overprinting Station
18.              Thinner
Make Dolphin Ink (I)
Specification DIPL 20
Mixture 40% with ink
Location Overprinting station
19.              Gear Box
Type VF-44-PMS
Make Bonfiglioli
Ratio 1 : 28
Location Printing
20.              Servo Motor
Sr. No.
Model 8MSA2L.RO-6
Make B & R Automation
Rating In 0.70A

Mn 0.6 Nm

Io 0.73A

Mo 0.6 Nm

Location Printing
21.              Gear box
Make Bonfiglioli
Ratio 1:30
Location Pulling station
Description Specification Meets Spec. (Yes/No) Verification Source Initials Date
22.              Servo motor
Sr. No.
Model 8MSA4M.RO-31
Make B & R Automation
Rating In 3.75A

Mn 4.6 Nm

Io 4.10A

Mo 5.3 Nm

Location Pulling station
23.              Gear box
Make Technocraft
Sr. No.
Ratio 7.5 : 1
Location Punching and perforation
24.              Servo motor
Sr. No.
Model 8MSA4L.RO-31
Make B & R Automation
Rating In 4.35A

Mn 6.4 Nm

Io  4.80A

Mo 7.5 Nm

Location Punching and perforation
25.              Vacuum pump
Make Indovac
Sr.No.
Model IV500
Rating 2 HP, 1440 RPM
Capacity 500 LPM
Description Specification Meets Spec. (Yes/No) Verification Source Initials Date
Pressure 26” of  Hg.
Location Blister pick up station
27        Suction cup
Make IWKA
Material Polyurethene
Location Blister pick up station
26.              Vacuum pump motor
Make Bhart Bijlee
Sr. No.
Supply voltage 415 V AC
Rating 2 HP
RPM 1415 RPM
Phase 3 Phase
Location Blister pick up station
27.              Main motor
Sr.No.
Model 8 MSA4L.EO.33
Make B & R Automation
Rating In 4.35 A

Io 4.80A

Mn 6.4 Nm

Mo 7.5 Nm

Location Main drive
28.              Machine mounts
Make AV Mount
Location Machine structure
29.              Gear Box
Make Bonfiglioli
Ratio 1:30
Location Main drive
Description Specification MeetsSpec. (Yes/No) Verification Source Initials Date
30.              PRC Scanner
Make Data logic
Model TL 10
Specification PNP / 24 V DC
Location Print Registration
31.              MMI
Make B & R Automation
Type 4 D 1170 Touch screen
Location Moveable
32.              PLC
Make B & R Automation
Type C 221
Rating 4 I/O cards & 1 relay card
Location Electronic control
33.              AC Drive (Main Motor)
Make B & R Automation
Model ACOPOS 1090
Location Electronic control
34.              AC Drive (Punching  Motor)
Make B & R Automation
Model ACOPOS 1090
Location Electronic control
35.              AC Drive (Pulling  Motor)
Make B & R Automation
Model ACOPOS 1045
Location Electronic control
Description Specification Meets Spec. (Yes/No) Verification Source Initials Date
36.              AC Drive (Feeding Motor)
Make B & R Automation
Model ACOPOS 1022
Location Electronic control
37.              AC Drive (Overprinting Motor)
Make B & R Automation
Model ACOPOS 1022
Location Electronic control
  • Equipment Number Identification
Equipment Name Sr.No. Equipment no. Checked By Date
1.PVC Unwinding motor
02 Motor for Al. Unwinding
03. Servo motor ( pulling station)
04. Servo motor                                           (Punching and perforation)
05. Main motor (Main drive)
  • 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
Cooling water To be provide
  • Material of Construction Verification
    • Rationale –

To verify that all assembly of PAM-PAC Blister Packing Machine  (BQS), has been manufactured as per the specification provided by the customer.

  • Test equipment –

Moly testing unit (To identify 304 or 316 materials)

  • Procedure –
    • Put a drop of Molybdenum solution on the material to be tested.
    • Take battery & keep anode at one end of the material and cathode at Moly drop.
    • If the solution turns pink and stays for around one minute, then it is SS316 & if the solution turns pink and immediately vanishes, then it is SS304.
  • Acceptance Criteria
    • All material of construction for the PAM-PAC Blister Packing Machine (BQS), shall meet the MOC provided in Design Qualification.
    • Material other than SS316 and SS304 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 Initials Date
Main frame M. S.
Cladding Stainless Steel 304
Hopper Stainless Steel 316
Linear vibrator Stainless Steel 316
Distributor plate Stainless Steel 316
Feeding sector Al. Anodized
Feeding

Channel

Al. Anodized
Good Bad Sorting Chute SS 304
  • Critical Instrument Calibration Verification 
  • Rationale –

To verify that all critical instruments for the PAM-PAC Blister Packing Machine  (BQS), 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 PAM-PAC Blister Packing Machine (BQS), shall be in a state of calibration.
  • Instrumentation List Results

 

Description Manufacturer Model Serial # Set point Operating Range Current

Calibration

Yes/ No Sign / Date
Temperature sensor

(Inlet water temp.)

Vibrator controller

(Linear vibrator)

Vibrator controller

(Rotary  vibrator)

Vacuum gauge
Pressure gauge
Temperature controller (Heating plate top)
Temperature controller (Heating plate bottom)
Temperature controller

(Sealing station)

Temperature controller

(forming station)

  • Installation Qualification Tests Status

The table below lists the tests performed and related results.

Test Number

 

Critical Feature

 

Pass / Fail Deviation Found
Pass Fail 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
S. No. Item Name Remarks Signature & Date

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

  • CONCLUSION

 

 

 

 

 

 

 

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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