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
Test Number	Critical Feature	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