Installation Qualification of Steam Sterilizer cum Bung Processor (Protocol)

The purpose of the Installation Qualification of Steam Sterilizer cum Bung Processor protocol is to establish documentary evidence to ensure that it received matches the Design specification and also to ensure that it is properly and safely installed.

💡Related Topics: Area Qualification Protocol in Pharmaceuticals

Protocol Contents for Steam Sterilizer cum Bung Processor IQ:

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 Supporting Utilities.
5.7	Identification Of Safety Feature(s)
5.8	Identification of standard operating procedure
5.9	Identification Of Component to be Calibrated
5.10	Verification of Drawings 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:

When signing this approval Protocol, it shows that you agree with the qualification approach described in this document. If a modification to the qualification approach is necessary, it shall be prepared and approved as an addendum. The protocol cannot be used for execution unless the following authorities approve it.

This Installation Qualification protocol for Steam Sterilizer cum bung processor 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 Steam Sterilizer cum bung processor and define the qualification requirements and acceptance criteria for the unit. Successful completion of these qualification requirements will provide assurance that the Steam Sterilizer cum bung processor 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 Steam Sterilizer cum bung processor 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 a Steam Sterilizer cum bung processor at the tablet manufacturing facility in XYZ Pharmaceutical & the subsequent documentation.
2.4	RESPONSIBILITY:
	The following shall be responsible; Quality Assurance officer / Executive – For preparation of protocol / Execution  Projects / Engineering Head – For execution  Production Head – For execution support Quality Assurance Head – For adequacy and final approval.

2.5

EXECUTION TEAM:

The satisfactory installation of the Steam Sterilizer cum bung processor shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Steam Sterilizer cum bung processor is installed and is satisfactorily integrated. The execution team is responsible for the execution of the installation of the Steam Sterilizer cum bung processor. The execution team comprises 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 comply with the specification.
3.5	All supporting electric and non-electric utilities of specified capacities are to be near the place of installation.

4.0	REVALIDATION CRITERIA:
	The machine has to be revalidated if:
	💡 There are any major changes in system components, that affect the performance of the system. 💡 After 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 Steam Sterilizer cum bung processor is designed for steam sterilization of various types of dry goods products such as machine parts, garments, rubber stoppers, media fills, components and pressure vessels, etc.

Sterilizer is designed for moist heat sterilization by using pure steam. Sterilizer designed by completely PLC operated with manual override in case of emergency. PLC is equipped with different cycles as per the requirements of the material i.e. for sterilization of garments, sterilization of empty glass flasks, rubber stoppers, machine parts, media for process simulation, and components the system description is divided into the following sections:

General, Technical summary along with Mechanical Construction, Design and Manufacturing Process, Control System, Cycle Operation, Documentation, Maintenance and recommended spare parts, Troubleshooting, etc.

The action of steam sterilizer on all the materials placed within the chamber is that the steam penetrates into the microorganisms present on and within the material thereby transferring the latent steam, which in turn will coagulate with the proteins, imparting a lethal effect on the organism, which will lead to the destruction of the organism.  

The steam sterilizer is made up of an SS sheet which is welded with a U-profile SS jacket. The sterilization chamber is provided with two vertical sliding doors which are also made up of SS reinforced with MS support structure. The door is operated with the help of pneumatic cylinders. When both door reaches at the end position the gaskets are pushed out automatically with the help of compressed air ejectors. When the gaskets retract the sterilizer chamber door slides automatically. The door sealing is made effective with the help of a tubular silicon rubber gasket. To ensure proper sealing the gaskets are activated with compressed air and retracted with the help of vacuum.

The sterilization chamber is insulated with resin-bonded glass wool, which helps in reducing the heat loss to the environment and ensures uniform distribution of temperature inside the chamber. This insulation is cladded with SS cover plate.

To ensure a leak-tight partition between the Sterile area (Class A unloading side) and the loading side an SS flush panel is provided on the partition wall and the outer cover of the steam sterilizer. All the joints, crevices are filled with silicon sealant to prevent leakages. The autoclave holds the vacuum with a rate of NMT 13 mbar per 10 minutes. All the automatic valves are closed when the autoclave chamber is at the ambient pressure. During the vacuum cycle except the vacuum valve, all other valves are closed.

The sterilizing grade filter is placed in a class A environment and connected to a chamber for the purpose of vacuum break. The filter is suitable for integrity testing and steam sterilization. Both the vertical sliding doors have an interlocking system in which the door does not open simultaneously. The doors do not open in any case during sterilization. The steam sterilizer has the ability to stand with a maximum of 3.0 kg /cm² pressure. The steam sterilizer has a safety valve, which will blow off if 0.5 kg/cm² exceeds than the working pressure. The system has an emergency stop so as to stop all the physical movement and operation of the machinery immediately, which is located along with the control panel.

5.2	INSTRUCTION FOR FILLING THE CHECKLIST
5.2.1	In case of compliance of the test use the word ‘Complies’ otherwise use ‘Does not comply‘ to indicate non-compliance.
5.2.2	For identification of the components of the equipment and utilities use the word ‘’yes’’ to show its presence and use ‘No’ to indicate the absence of the identity
5.2.3	Give 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
01	Safety valve for chamber
02	Safety valve for jacket
03	Air pressure regulator
04	Gasket air pressure regulator
05	Air pressure switch
06	Gasket vacuum switch
07	Vacuum valve
08	Pure steam supply
09	Sealing water for vacuum pump
10	Compressed air supply
11	Header outlet (Drain connection)
12	Chamber vacuum line
13	Validation probe
14	WFI (Distilled water)
15	Purified water
16	Detergent Solution
17	Silicon solution
18	Air heater nozzle & piping connection
19	Electric power supply
20	Electric connection between power & Control panel etc.
21	Pneumatic instruments tubing
22	Pneumatic connection leakages
23	Duct flanges bolted connections
24	System interlock functioning
	a) Emergency
	b) Air pressure low
	c) Power failure
	d) Door open temperature not reached
	e) Sterile or non-sterile door open
	f) Control temperature sensor faulty
	i) Final vacuum problem
	g) Door Between
	h) Initial vacuum problem
	j) Preheating temperature problem
	k) Pressure release problem
	l) Vacuum release problem
	m) Gasket release problem
	n) Sterile temperature problem
	o) Chamber pressure high
	p) Water level problem
25	Properly Mounted and Supported
26	Properly labeled and identified

5.4	IDENTIFICATION OF MAJOR COMPONENTS:
	Describe each critical component and check them and fill out the inspection checklist.

System Components	Design Specification	Complies / Does Not Comply	Checked By(Sign)	Date
1) Validation gland adaptor	Size – 2” Triclover
	No of holes – 8 nos.
	Gland – Silicon
	Gland diameter – 6MM
	MOC – SS 316L
	Make – Pharmalab
	Qty – 02
	Location 1 – At the left side of chamber
	Location 2 – At the right side of chamber
2) Sampling valve	Size – 25 MM
	MOC – SS 316L
	Diaphragm – Silicon
	Operation – Manual
	Make – Pharmalab
	Qty – 01
	Location – Chamber condensate line
3) Safety valve	Size – ¾” BSP female
	MOC – SS 316L
	Make – Shakti
	Range – 0 – 43 PSI
	Type – Spring loaded
	Qty – 02
	Location 1 – on the chamber
	Location 2 – on the jacket
4) Compound pressure gauge	Dial size – 4”
	Range – -1 to 3.5 kg/cm2
	Make – Waree
	Mounting – Panel mounting
	End connection – 3/8” BSP
	MOC – Body: SS304Movement: SS304Burden socket: SS316L
	Type – Analogue
	Qty – 02
	Location 1 – on front facia at sterile side
	Location 2 – on front facia at non-sterile side
5) Compound pressure gauge	Dial size – 2 – ½”
	Range – -1 to 3.5 kg/cm2
	Make – Warre
	Mounting – Panel mounting
	End connection – ¼” BSP
	MOC – Body: SS304 Movement: SS304 Burdon socket:SS316L
	Type – Analogue
	Qty – 02
	Location 1 – On front facia at non-sterile side
	Location 2 – On front facia at non-sterile side
6) 2 Way pneumatic valve	Make – Micro pneumatics
	Model – 2 way, 3 p/c
	MOC of working parts- SS 316L
	MOC of the body – SS 316
	Type–ball valve with full bore
	Size – ½”
	Seal – P.T.F.E
	Actuator – single acting (spring return)
	Operation – pneumatically operated
	Solenoid valve – 24 V AC
	Qty – 08
	Location 1 – At the venting line
	Location 2 – At the vacuum break line
	Location 3 – At the side drain line
	Location 4 – At the side drain bypass line
	Location 5 – At the air agitation line
	Location 6 – At the side spray line
	Location 7 – At the silicon line
	Location 8 – At the detergent line
7) 2 Way pneumatic valve	Make – Micro pneumatics
	Model – 2 way, 3 p/c
	MOC of working parts- SS 316L
	MOC of the body – SS 316
	Type–ball valve with full bore
	Size – 1”
	Seal – P.T.F.E
	Actuator – single-acting
	(spring return)
	Operation – pneumatically operated
	Solenoid valve – 24 V AC
	Qty – 10
	Location 1 – Steam inlet to chamber
	Location 2 – Steam inlet to jacket
	Location 3 – At the chamber condensate line
	Location 4 – At the chamber vacuum line
	Location 5 – At the steam agitation line
	Location 6 – At the drain line
	Location 7 – At the main drain line
	Location 8 – At the water recirculation line
	Location 9 – At the D.M. water inlet line
	Location 10 – At the distilled water inlet line
8) Pressure gauge	Dial size – 4”
	Range – 0 to 4.2 kg/cm2
	Make – Warre
	Mounting – Panel mounting
	End connection – 3/8” BSP
	MOC – Body: SS3304Movement: SS304Burden socket: SS316L
	Type – Analogue
	Qty – 02
	Location 1 – Panel mount at the sterile side
	Location 2 – Panel mount at the non-sterile side
9) Air pressure switch	Make – Orion
	Model – MGH07CB10
	Range – 0.5 to 7 kg/cm2
	Diff. pressure – 0.4 kg/cm2
	MOC – Brass
	Diaphragm – Teflon
	Qty – 01
	Location – On the outlet of the air pressure regulator
10) Air vacuum switch	Make – Orion
	Model – MNV00CB11
	Range –100 to 750mm of hg
	Diff. pressure – 100 mm of hg
	MOC – Brass
	Diaphragm – Teflon
	Qty – 02
	Location 1 – Door -1 gasket vacuum line
	Location 2 – Door – 2 gasket vacuum line
11) Jacket pressure switch	Make – Orion
	Model – MAH03CS10
	Range – 0.2 to 2.6 kg/cm2
	Diff. pressure – 0.2 to 1.5 kg/cm2
	Test pressure – 12 kg/cm2
	End connection – ¼” BSP female
	Qty – 01
	Location – On the jacket
12) Float-type steam trap	Size – 15NB
	Model – FT-14CI-10
	Make – Spirax
	Type – Balanced pressure thermostatic trap
	Max. Working pressure – 13 kg/cm2
	Max working temperature – 120c
	MOC – body: C.I.Cover: C.I. Valve seat: SS 410
	Qty – 02
	Location 1 – chamber condensate line
	Location 2 – jacket condensate line
13) Pressure transmitter	Make – Keller
	Model – 23 R
	MOC – SS 316L
	Range – -1 to 3 kg/cm2
	Mounting – direct mounting
	Output – 4 to 20 mA
	Qty – 01
	Location – On the chamber
14) Vacuum pump	Make – Vindivac
	Model – RTZ, 3HP
	RPM – 2850
	Vacuum capacity – 710 mm of hg
	Flow rate – 50 M3 /hr
	Qty – 01
	Location – Service floor
15) Vent filter with housing	Housing model – ZLK9010G23H4
	Model – SLK7002PFRP
	Rating – 0.2 micron
	Make – Pall
	Filter length – 5”
	Medium – PTFE
	MOC – SS316L
	Housing gasket – Silicon
	Qty – 01
	Location – at the sterile side in the vacuum break line
16) Air pressure regulator	Make – Festo / SMC
	Model – ¼”
	Size – ¼” mm
	Qty – 01
	Location – Main airline
17) Gasket air pressure regulator	Model – ¼”
	Make – Festo / SMC
	Size – ¼”
	Qty – 01
	Location – air gasket sealing line
18) Non return valve	Make – VB
	Size – 25mm
	MOC – SS316L
	Qty – 01
	Location – at the chamber vacuum line
19) Needle valve	Make – shakti
	Size – ½” BSP female
	MOC – SS316L
	Qty – 01
	Location – at the chamber condensate bypass line
20) Ball valve	Size – 3/8”
	Model – 3 piece
	MOC – SS316L
	Qty – 02
	Location 1 – at the jacket condensate bypass line
	Location 2 – at the side of the chamber for sampling
21) Temperature sensor	Make – techno
	Class – A
	MOC – SS316L
	Seath size – 4.5 mm
	Length of seath – 55mm
	Range – 0degree – 200 degree
	Type – PT 100
	Element – Dual
	Qty – 05
	Connection – Triclover
	Location 1 – at the chamber condensate line
	Location 2 – at the left side of the chamber – top
	Location 3 – at the left side of the chamber – bottom
	Location 4 – at the right side of the chamber – top
	Location 5 – at the right side of the chamber – bottom
22) Strainer	Make – Shakti / karan
	MOC – SS304
	Size – ½” BSP female
	Qty – 02
	Location 01 – at the chamber condensate line
	Location 02 – at the jacket condensate line
23) Solenoid valve	Size – ¼” BSPF
	Make – SMC / Aira
	Volt – 24V AC
	MOC – Brass
	Qty – 05
	Location 1 – at the inlet of the vacuum pump
	Location 2 at the door – 1 gasket seal line
	Location 3 – at the door –2 gasket seal line
	Location 4 – at the door – 1 gasket vacuum line
	Location 5 – at the door – 2 gasket vacuum line
24) Door limit switch	Model – JLSL – 2
	Make – Jay Balaji
	Contact – 1 NO + 1 NC
	Qty – 04
	Location 1 – at the sterile side door open the position
	Location 2 – at the sterile side door close the position
	Location 3 – at the non-sterile side door open position
	Location 4 – at the non-sterile side door close the position
25) Door safety switch	Model – JLSPBA
	Make – Jay Balaji
	Contact – 1 NO + 1 NC
	Qty – 04
	Location 1 – on the sterile side door
	Location 2 – on the sterile side door
	Location 3 – on non-side door
	Location 4 – on the non-sterile side door
26) Printer	Model – LX 300
	Make – Epson
	Type – Dot matrix
	Qty – 01
	Location – at the bottom box of the control panel
27) Chart recorder	Model – 4102M
	Type  – 6 points strip chart recorder
	Input – channel –1pressure 0 to 10mv
	Channel–2 Temperature, PT-100
	Channel–3 Temperature, PT-100
	Channel–4 Temperature, PT-100
	Channel–5 Temperature, PT-100
	Channel–6 Temperature, PT-100
	Make – Eurotherm
	Qty – 01
	Location – on the paneling of non-sterile side
28) Air agitation regulator with gauge	Model – ½”
	Make – Festo / SMC
	Size – ½”
	Qty – 01
	Location – air agitation line
29) Float switch	Type – magnetic
	Temp. range – 150 deg. C
	MOC – SS316L
	Make – Mahalakshmi/ crystal /punetectrol
	Qty – 01
	Location – at the side of the chamber
30) Circulation water pump	Model – CHI-2-50
	Make – Grundfos
	MOC – SS316L
	Gasket – EPDM
	Qty – 01
	Location – recirculation water line
31) Recirculation filter with housing	Filter size – 40 microns
	Type – Wire mesh
	Filter length – 10” (INCH)
	Gasket – silicon
	Water flow rate – 2.5 to 3 CMH
	Make–Tec fill
	Housing MOC – SS316L
	Qty – 01
	Location – recirculation water line
32) Drum motor	Type – Geared motor flange mounted
	HP – 0.75
	RPM – 16
	Service factor – 2.1
	Shaft diameter –  44 MM
	Frame size – NZ 3 90 L 8
	Make – Remi
	Qty – 01
	Location – on the chamber
33) Dosing pump	Model – HC-100-04-05
	Type – Metering
	Diaphragm – Electronics
	Flow rate – 4LPH@ 5 Bar Pressure
	Make – AQUA
	Qty – 02
	Location 1 – at the inlet of the silicon line
	Location 2 – at the inlet of the detergent line
34) Control panel	Model – automatic with manual operation facility in case of PLC failure
	Enclosure – SS 304,1.6 mm thick with polycarbonate cover on MMI
	Panel location – 2 meters away from the machine
	Size in mm – approx 400 D X 1500 H
	PID controller – Model: MC5438 / P48UMake : Max-thermo / Radix
	PLC – Mitsubishi
	MMI – Beijer
	Temperature transmitter – Range: 0 to 200 deg CMake: RadixQty: 05 nos.
	Transformer – Bhatt Magnetic / Narmada
	3 pole rotary switch – sulzer
	Overload relay – L&T
	ELCB + MCB – Hagger / Datar
	Signal distributor – Radix
	Contactor – L& T
	MCB – 3 Pole – Hagger / Indfoss / Datar
	6-channel relay module – Phonix / Brisk
	D.C. source – Meanwell
	2 way 4 pole switch – Sulzer

Sr. No.		Component		Material of Construction	Method of verification	Checked By Sign / Date
1.		Chamber 6mm Thick plate		SS 316 L	Visually with test certificate
2.		Jacket shell 10SWG sheet		SS 316 L	Visually with test certificate
3.		Door 14 mm thick plate		SS 316 L	Visually with test certificate
4.		10 x10 mm SQ. Bar for jacket		SS 316 L	Visually with test certificate
5.		Chamber 1” DIA ROD		SS 316 L	Visually with test certificate
6.		Baffel plate 16 SWG sheet		SS 316 L	Visually with test certificate
7.		25 mm OD x 2 mm thick plate		SS 316 L	Visually with test certificate
8.		6 mm OD x 1 mm thick pipe		SS 316 L	Visually with test certificate
9.		¾” OD 16 SWG WT pipe		SS 316 L	Visually with test certificate
10.		Ø12.7 mm x 1 mm WT pipe		SS 316 L	Visually with test certificate

5.6	IDENTIFICATION OF SUPPORTING UTILITIES:

UTILITY	PROPERLY IDENTIFIED & CONNECTED (YES/NO)	CHECKED BY (SIGN)	DATE
1) Electricity: Specification: 415 V, 3 Ph. 50 Hz Requirement: 5 KW
2) Pure steam supply Specification:  3 kg/cm² pressure dry and saturated pure steam Consumption:  = 120 kg / Hr.
3) Compressed Air Supply Specification: Dry, clean, and Filtered at 8 kg/cm² minimum pressure Requirement: 8 CFM

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

Safety Features Description	Function	Identified By (Sign)	Date
1) Door Safety	In case of door open
2) Emergency off, if activated stops the process	For Equipment & Operator Safety
3) Control temperature sensor faulty	Process will stop
4) Chamber safety against overpressure of the steam	The safety valve will open at 2.2 kg/cm2 pressure. PLC will cut off the steam supply control valve when the steam pressure in the chamber reaches at 2.2 kg/cm2 and the venting valve will get open to release the chamber pressure.
5) Jacket safety against overpressure of the steam	Safety valve open at 2.2 kg/cm2 pressure Jacket pressure switch

5.8	IDENTIFICATION OF STANDARD OPERATING PROCEDURE (SOP):
The following Standard Operating Procedures were identified as important for the effective performance of the Steam sterilizer cum bung processor.
1	Operation and cleaning of Steam sterilizer cum bung processor
2	Preventive maintenance of Steam sterilizer cum bung processor

5.9	IDENTIFICATION OF COMPONENT TO BE CALIBRATED
1. Pressure gauge 2. Temperature sensors 3. Temperature transmitter

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:
	Following Abbreviations are used in the installation qualification protocol of Steam sterilizer cum bung processor.
P & I: Piping and instrumentation PLC: Programmable logic controller S.S: Stainless steel SSB: Steam sterilizer cum bung processor

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	ANNEXURES
	Following Annexures are used in the installation qualification protocol of Steam sterilizer cum bung processor.

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

All tests required by this protocol have been verified as completed, reconciled, and attached to this protocol or included in the qualification summary report. It has been verified that all amendments and discrepancies are documented, approved, and attached to this protocol.

The signature in the block below indicates that all items in this qualification report of Steam sterilizer cum bung processor have been reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily resolved.

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		PROJECTS / ENGINEERING
		PRODUCTION
		QUALITY ASSURANCE