INSTALLATION QUALIFICATIONS OF COMPRESSION MACHINE

INSTALLATION QUALIFICATIONS OF COMPRESSION MACHINE

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 B4 Type 35 Station. “B” Tooling Tab, Machine, 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 equipments will be installed in accordance with current Good manufacturing Practices.
  • SCOPE:

This procedure applies to the installation qualification of B4 Type 35 Station. “B” Tooling Tab, Machine and its accessories to be installed at Pharma Company.

  • 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 B4 Type 35 Station. “B” Tooling Tab, Machine 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
    • 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 are available.
  • Review the documents and drawings for completeness and exactness with the installed units.
  • Attach the copies of the drawings 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:

PASS                                      FAIL

Verified By:      _______________________            Date:   ______________

Checked By:   ________________________            Date:     ______________

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

  • Purpose

To verify that each major component of the B4 Type 35 Station. “B” Tooling Tab, Machine are 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 B4 Type 35 Station. “B” Tooling Tab, Machine are 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 Results
Description Specification Meets

Spec. (Yes/No)

Verification Source Signature Date
1.           Equipment Description
Equipment Name B4 Type 35 Station. “B” Tooling Tab, Machine
Equipment Code
Model No. FXD-B4-35 “B”
Serial No
Turret RPM Min = 15

Max = 40

Output (Tablet/ Hour) Min = 70,000

Max = 1,68,000

Hopper capacity
No of Hopper  1 Nos.
Tablet diameter Max = 16.1 mm
Depth of fill 15 mm
Max. Operating pressure 60 KN [6 Tons]
Overall dimensions (in mm, with guards open) 1880 X 2040 X 2000
2.           Electrical / Mechanical
2.1.         Main Motor
Type 3 Phase
Sr. No. SLGM02984
Make CROMPTON
Capacity 5HP, 415V,50Hz
2.2.         VFD
Model
Sr. No. 010202531895090002A
Cat. No.
Make EMOTRON
2.3.         Hydraulic Gauge
Sr. No.
Range
Least Count
Make
2.4.         Oil Pump
Model No. DMHT-600-5 (Dx)
Sr.No.
Make DROPCO ENG
LUBRICATION SYSTEM ONE SHOT LUBRICATION (MANUAL HANDEL TYPE PUMP)
2.5.         Safety Guard Interlock Switch
Qty.
Sr. Nos.
Make
2.6.         Upper Punch Sensor
Sr. No.
Power rating
Make
2.7.         V-Belt
Size
Qty.  

 

3.           Control Panel
3.1.         Main Drive 
Controls
Qty.

 

3.2.         Electro Magnetic Clutch
Controller
Qty.
3.3.         Safety Guard Interlock / Bypass Switch
Qty.
3.4.         Digital Counter
Type
Model
Sr. No.
Options
3.5.         Ampere Meter
Make
Location
Range
3.6.         Emergency Switch
Qty.

 Conclusions / Comments:

PASS                                      FAIL

Verified By:                ________________________            Date:   ______________

Reviewed By:             ________________________            Date:   ______________

  • 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

Conclusions / Comments:

PASS                                      FAIL

Verified By:                ________________________                        Date:   ______________

Reviewed By:             ________________________                        Date:   ______________

  • Material of Construction Verification
  • Rationale –

To verify that all assembly of B4 Type 35 Station. “B” Tooling Tab, Machine 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 B4 Type 35 Station. “B” Tooling Tab, Machine 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 Signature Date
Turret SGI
Turret Depot Ring SS 316
Discharge Spout SS316
Hopper SS316
Hopper Lid SS316

 Conclusions / Comments: 

PASS                                      FAIL

Verified By:                ________________________            Date:   ______________

Reviewed By:             ________________________            Date:   ______________

  • Critical Instrument Calibration Verification 
  • Rationale –

To verity that all critical instruments for the B4 Type 35 Station. “B” Tooling Tab, Machinehas 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 document.
  • Acceptance Criteria
  • All critical instrumentation for the B4 Type 35 Station. “B” Tooling Tab, Machine shall be in a state of calibration.
  • Instrumentation List Results
Description Make Least Count Set point Operating Range Current

Calibration

Yes/No Sign / Date
Hydraulic Gauge

Conclusions / Comments:

PASS                                      FAIL

Verified By:                ________________________            Date:   ______________

Reviewed By:             ________________________            Date:   ______________ 

  • 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

Sr. No.

Item Name

Remarks

Signature & Date

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

  • CONCLUSION

Prepared by                                Reviewed By                         Approved by

Vitamin with Ginseng 200 mg Capsules

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