IQ of High Speed Linear Vial Washing Machine

Installation Qualification of High Speed Linear Vial Washing Machine protocol is to establish documentary evidence to ensure that the Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from the washing machine) received matches the Design specification.

Related: Area Qualification Protocol in Pharmaceuticals

SERIAL NO.	ITEM DESCRIPTION
1.0	PROTOCOL APPROVAL
2.0	OVERVIEW:
2.1	Objective
2.2	Purpose
2.3	Scope
2.4	Responsibility
2.5	Execution Team
3.0	ACCEPTANCE CRITERIA
4.0	REVALIDATION CRITERIA
5.0	INSTALLATION QUALIFICATION PROCEDURE
5.1	System Description
5.2	Instruction for Filling the Checklist
5.3	Installation Check List
5.4	Identification of Major Components
5.5	Verification of Material Of Construction
5.6	Identification of components to be calibrated
5.7	Identification of Control and Safety Devices
5.8	Identification of Supporting Utilities
5.9	Verification of Equipment Installation
5.10	Verification of Drawing and Documents
5.11	Abbreviations
5.12	Deficiency And Corrective Action(s) Report(s)
5.13	Annexure(s)
6.0	INSTALLATION QUALIFICATION FINAL REPORT
6.1	Summary
6.2	Conclusion
6.3	Final report approval

1.0	PROTOCOL APPROVAL:

The signing of this approval page of the Protocol indicates agreement with the qualification approach described in this document. If a modification to the qualification approach becomes necessary, an addendum shall be prepared and approved. The protocol cannot be executed unless approved by the following authorities.

This Installation Qualification protocol for Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from the washing machine) has been reviewed and approved by the following persons:

FUNCTION	NAME	DEPARTMENT	SIGNATURE	DATE
PREPARED BY		QUALITY ASSURANCE
REVIEWED BY		PROJECTS / ENGINEERING
REVIEWED BY		PRODUCTION
APPROVED BY		QUALITY ASSURANCE

2.0

OVERVIEW:

2.1	OBJECTIVE:
	The objective of developing and executing this protocol is to collect sufficient data pertaining to the Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from the washing machine) and define the qualification requirements and acceptance criteria for the unit. Successful completion of these qualification requirements will provide assurance that the Automatic High-Speed Linear Vial Washing Machine was installed as required in the manufacturing area.
2.2	PURPOSE:
	The purpose of this protocol is to establish documentary evidence to ensure that the Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from the washing machine) received matches the Design specification and also to ensure that it is properly and safely installed.
2.3	SCOPE:
	This Protocol is applicable to the installation of an Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from the washing machine) at the Dry injection manufacturing facility in XYZ Pharmaceutical & the subsequent documentation.
2.4	RESPONSIBILITY:
	The following shall be responsible; Departmental Head: Mention their Responsibilities

2.5

EXECUTION TEAM:

The satisfactory installation of the Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from the washing machine) shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from the washing machine) is installed and is satisfactorily integrated.The execution team is responsible for the execution and installation of Automatic High-Speed Linear Vial Washing Machine Execution team is comprised of:

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
PROJECTS / ENGINEERING
PRODUCTION
QUALITY ASSURANCE

3.0	ACCEPTANCE CRITERIA:
3.1	The equipment shall fulfill all the selection criteria and its individual application
3.2	The equipment shall comply with the specification mentioned in the user requirement specification.
3.3	It shall be complying with all the designed specifications.
3.4	The Material of Construction (MOC) shall be complying with the test certificate.
3.5	All supporting electrical and non-electrical utilities of specified capacities are to be near the place of installation.

4.0	REVALIDATION CRITERIA:
	The machine has to be revalidated if
	💡Any major changes in system components affect the performance of the system. 💡After a major breakdown maintenance is carried out. 💡As per the revalidation date and schedule.

5.0	INSTALLATION QUALIFICATION PROCEDURE:
5.1	SYSTEM DESCRIPTION

The Principle of Automatic High-Speed Linear Vial Washing Machine is designed for washing of vials (5ml to 30ml) and these two conveyor for loading vials to the washing machine and unloading them from the washing machine.

1. The Automatic High-Speed Linear Vial Washing Machine works on the principle of jet washing of the individual vials in a mouth-down position by a series of jets.
2. The vials are loaded on the unloading station by placing a tray of vials on it. The complete layer of the vials is pushed out to the machine platform through a loading conveyor.
3. The vials go to in feed lifter with the help of in feed conveyer. Then this in-feed lifter carries the vials into the individual pockets.
4. After vials go into the pockets channel runs to the backside (Anticlockwise). During this process, the in-feed lifter comes back and carries other vials for washing continuously.
5. The index channel of vials carries forward at a time. During each stoppage of this movement, the nozzle manifold raises up and a nozzle enters the mouth of each individual vial.
6. A solenoid valve in the water and air lines is now activated and a jet of air/water hits the inside of the vial to thoroughly clean it.
7. An external cleaning station is also provided. The standard washing sequence provided is as under:
   • 1^st wash: Compressed air.
   • 2^nd wash: Re-circulated water.
   • 3^rd wash: Re-circulated water.
   • 4^th wash: Compressed air.
   • 5^th wash: Purified water.
   • 6^th wash: Compressed air.
   • 7^th wash: Purified Water.
   • 8^th wash: Compressed air.
   • 9^th wash: WFI.
   • 10^th wash: Compressed air.
8. These washed vials are then taken away from the pockets with the support of a vial guide plate and come out on the out-feed lifter.
9. The outfeed lifter comes down and the washed vials (12 vials at a time) are transferred to the outfeed conveyor for further process.

Equipment Details:

Equipment Name: Automatic High-Speed Linear Vial Washing Machine

Make: Make Name

Model No. : XYZ

Capacity: 150 vials/Minute (5ml to 30ml vials)

5.2	INSTRUCTION FOR FILLING THE CHECKLIST
5.2.1	In case of the compliance of the test use the word ‘Complies’ otherwise use ‘Does not comply‘ to indicate non-compliance.
5.2.2	To identify equipment and utilities components, use “yes” for presence and “No” for absence of identity.
5.2.3	Give the detailed information in the summary and conclusion part of the Installation Qualification report.
5.2.4	Whichever column is blank or not used ‘NA’ shall be used.

5.3	INSTALLATION CHECKLIST:
	The installation checklist is as follows:

Sr. NO.	STATEMENT	YES / NO	CHECKED BY(SIGN)	DATE
	Verify that the “As Built” drawing is complete and represents the design concept.
	Verify that major components are securely anchored and shock proof.
	Verify that there is no observable physical damage.
	Verify that there is sufficient room provided for servicing.
	Safe electrical connections, Water lines and Compressed air are fitted.
	Equipment identification nameplate visible.
	Verify that all piping and electrical connections are done according to the drawings.
	Safe electrical connections, Water lines, and Compressed air are fitted.
	Wiring diagram affixed to inside section of control panel.
	Units installed on foundation are secure in place as per manufacturer’s recommendations.
	Check the dimensions for the infeed conveyor: 1500 mm (L) X 345mm (W)
	Check the dimensions for the outfeed conveyor: 340 mm (L) X 900mm (W)

5.4	IDENTIFICATION OF MAJOR COMPONENTS:
	To Verify that major components as identified below comply with the desired specifications.

System components	Design Specifications	Complies / does not comply	Checked By (Sign.)	Date
Equipment description	Name: Automatic High-Speed Linear vial washing machine Make: Ambica Engineering works Model: AHLVW – 150 Output: 150 vials/minute of 5ml to 30 ml
Conveyor width	900 mm
Pressure gauge	Qty: Five No., Range:  0 – 4kg/cm2
Main motor	3 Phase, 415Volt, 50Hz, 1 HP, 0.75KW,  1390 RPM, Make –Remi
Pump motor	3 Phase, 415Volt, 50Hz, Each 350W, 960 RPM, Three no. Make– Grunfors
Conveyor drive motor (Infeed)	3 Phase Induction motor, 415Volt, 0.5HP, 1365 RPM, Make– Sabar,
Dimension of infeed conveyor	1500(L) x 345(W) mm, MOC – SS304
Conveyor drive motor (outfeed)	3 Phase Induction motor, 415Volt, 0.5HP, 1365 RPM, Make– Sabar,
Dimension of outfeed conveyor	340(L) x 900(W) mm, MOC – SS304
PLC and MMI	Messung, VFD – T verter, 220V, 0.75KW, One no.
Main drive gearbox	Reduction type with helical gear drives AMBICA make
Conveyor drive gear motor	Make- Ambica, 0.5 HP
Filter housing	Four no.
Washing Nozzle	12 x 10
Vial pocket	12 x 40
Limit switch	Four no., AC 15 at 415 volt, 1.5Amp., Make – Grunfors

5.5	VERIFICATION OF MATERIAL OF CONSTRUCTION:
	Verify the material of construction from test certificates.

Sr. No.	Components	MOC	Method of verification	Checked By sign./Date
1.	Washing Needles	SS 316	Visually with test certificate
2.	All Tanks	SS 316	Visually with test certificate
3.	Machine frame and structure	SS 304	Visually with test certificate
4.	All side covers	SS 304	Visually with test certificate
5.	Vial pocket	HDPE	Visually with test certificate
6.	All prism patty	UHMW	Visually with test certificate
7.	Pusher	UHMW	Visually with test certificate
8.	Loosening patty	UHMW	Visually with test certificate
9.	Conveyor belt	SS 304 wire mesh type	Visually with test certificate
10.	Pockets Channel	SS 304	Visually with test certificate
11.	Main Pocket drive chain	SS 316	Visually with test certificate
12.	Pocket drive chain sprocket	Nylocast	Visually with test certificate
13.	Drive cam	Harden material	Visually with test certificate
14.	Indexing drive cam	Harden material	Visually with test certificate
15.	All shaft	SS 304	Visually with test certificate
16.	All pipe fittings for the drain	SS 304	Visually with test certificate
17.	All rubber gasket	Silicon	Visually with test certificate
18.	All Tanks	SS 316	Visually with test certificate
19.	All pipe fittings	SS 316 with Silicon	Visually with test certificate

5.6	IDENTIFICATION OF SUPPORTING UTILITIES:
	Identify and record the supporting utilities and their details in the following tables:

UTILITY	PROPERLY IDENTIFIED & CONNECTED (YES/NO)	CHECKED BY (SIGN)	DATE
1) Electricity:Specification: 415 VAC, 3 Ph.
2) Compressed air (20CFM)0 – 4 Kg/cm2
3) Recycle water (400 Ltrs./hour)0 – 4 Kg/cm2
4) Purified water (400 Ltrs../hour)0 – 4 Kg/cm2
5) Purified water (400 Ltrs../hour)0 – 4 Kg/cm2
6) WFI (300 Ltrs./hour)0 – 4 Kg/cm2

5.7	IDENTIFICATION OF SAFETY FEATURES:
	Identify and record the safety features (if any) and their function in the following tables:

Sr.No.	Safety feature Description	Function	Identified By(Sign)	Date
1.	Check for the overload safety devices	The electric circuit should be provided with a miniature circuit breaker. for motor safety.
2.	Check for Earth connection	Earth connection should be provided properly.
3.	Two Emergency stop	One on the main panel and another at the backside cover for Equipment and operator safety.
4.	Discharge vial jam	Limit switches should be provided inside the indexing drive box. For Equipment safety.
5.	Pusher vial jam	A limit switch should be provided on the pusher clutch. For Equipment and product safety.
6.	Lifter vial jam	A limit switch should be provided on the lifter clutch. For Equipment and product safety.
7.	Infeed vial jam	A limit switch should be provided on the Infeed drum clutch. For Equipment and product safety.

5.8		IDENTIFICATION OF STANDARD OPERATING PROCEDURE (SOP)
Operation and cleaning of Automatic High-speed linear Vial washing machine
1.	Operation and cleaning of Automatic High speed linear Vial washing machine
2.	Preventive maintenance of Automatic High-speed linear Vial washing machine

5.9	IDENTIFICATION OF COMPONENT TO BE CALIBRATED:
	Identify and record the instruments to be calibrated in the following tables:

Sr.No.	Name of the Instrument	Location	Specification	Identified By(Sign	Date
1.	Pressure gauge	Compressed air supply line	0 – 4 kg/cm2 Make: Micro
2.	Pressure gauge	Recycle water supply line	0 – 4 kg/cm2 Make: Micro
3.	Pressure gauge	Purified water supply line	0 – 4 kg/cm2 Make: Micro
4.	Pressure gauge	Purified water supply line	0 – 4 kg/cm2 Make: Micro
5.	Pressure gauge	WFI supply line	0 – 4 kg/cm2 Make: Micro

5.10	VERIFICATION OF DRAWING AND DOCUMENTS:
	The following documents are reviewed and attached as listed below:

Sr. No.	DRAWING AND DOCUMENT DETAIL	CHECKED BY (SIGN)	DATE

5.11	ABBREVIATIONS
The following Abbreviations are used in the installation qualification protocol of the Automatic High-speed linear Vial washing machine.
P & I: Piping and instrumentation VFD: Variable frequency drive UHMW: Ultra high molecular weight polyethylene HDPE: High-density polyethylene VWM: Vial washing machine

5.12	DEFICIENCY AND CORRECTIVE ACTION (S) REPORT (S)
The following deficiency was identified and corrective actions were taken in consultation with the validation team.

Description of deficiency:

Corrective action(s) taken:

 Reviewed By:

 Date

5.13 Annexure(s):

Sr.No.	Annexure No.	Title of Annexure

6.0	INSTALLATION QUALIFICATION FINAL REPORT:

All the IQ data sheets and discrepancy reports shall be reviewed by the validation team to prepare a summary report. The summary of IQ shall be used to draw a conclusion for approval of the installation qualification report.

6.1	SUMMARY
6.2	CONCLUSION

6.3 FINAL REPORT APPROVAL

It has been verified that all tests required by IQ of High-Speed Linear Vial Washing Machine protocol are completed, reconciled, and attached to this protocol or included in the qualification summary report. Verified that all amendments and discrepancies are documented, approved, and attached to this protocol.

Signature in the block below indicates that all items in this qualification report of the Automatic high-speed linear Vial washing machine have been reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily resolved.

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		PROJECT / ENGINEERING
		PRODUCTION
		QUALITY ASSURANCE