IQ OF DRY SYRUP FILLING MACHINE
INSTALLATION QUALIFICATION OF DRY SYRUP FILLING MACHINE
Contents
- Pre Execution Approval
- Objective
- Equipment Description
- Participants Log
- Installation Qualification Checklist
- Sub-Component CheckList
- Component Location List
- MOC Verification List
- Test / Inspection Reports
- Utility Verification List
- Attachment Log
- Summary, Conclusion, and Recommendation
- Abbreviations
- Post Execution Approval
PRE-EXECUTION APPROVAL
Prepared by
By signing, the person is responsible for the accuracy of this Installation Qualification and agrees with the content
Approved by
The signature on this page indicates that this document has been reviewed, checked, and approved by the concerned person. It shall be signed and dated.
OBJECTIVE:
Installation Qualification protocol for Automatic Rotary Volumetric Dry Syrup Filling with Pick & Place type Screw Capping Machine, Head: 16 x 8 is written to comply with requirements for Qualification. Qualification of critical equipment is a GMP requirement.
Scope of Qualification:
The scope is limited to Automatic Rotary Volumetric Dry Syrup Filling with Pick & Place type Screw Capping Machine.
The purpose of this protocol is as follows:
- To provide documented evidence that the Automatic Rotary Volumetric Dry syrup Filling with Pick & Place type Screw Capping Machine, Head: 16 x 8 is installed as per design.
- To collect the required information for installation of Automatic Rotary Volumetric Dry Syrup Filling with Pick & Place type Screw Capping Machine, Head: 16 x 8 in order to assure the equipment functions as per the desired operating specifications.
EQUIPMENT DESCRIPTION:
The Automatic Rotary Volumetric Dry syrup Filling with Pick & Place type Screw Capping Machine, Head: 16 x 8 works on volumetric principle Volumetric powder wheel for filling pre-set powder volume in the bottle and subsequently screw capping on the bottle.
Basic Constructional Features:
- The Unit is compact, versatile, and enclosed in SS elegantly hair finish body.
- S. Slat Conveyor.
- The SS Powder wheel with Piston set and SS funnels.
- All contact parts are made of Stainless Steel 316.
- All non-contact parts shall be of SS304 / cladded with SS 304.
- Totally enclosed drive with a gear box mounted on a structure.
Description:
- The drive unit is fitted with foot mounted Motor on a reduction gearbox.
- A separate A.C. frequency drive is fitted with the machine for speed control of the conveyor.
- This worm gear reduction is the major speed-reducing unit.
- The drive assembly with gearbox and motor is mounted on the structure.
- The funnel plate has 24 Nos. The funnels and Powder Wheel is mounted on the center pipe.
- The lifter assembly lifts the bottle when it comes below the funnel and tight-fits it into a funnel for powder filling.
- Powder Wheel consists of a Piston set and a vacuum plate with back spring pressure that does not leave any clearance.
- A precise volume of powder is sucked into the powder wheel during the vacuum according to the piston length.
- The powder wheel is mounted on the filling head and its drive is taken from the top plate bottom assembly through a chain drive.
- A vibrating mechanism is provided for a vibrating funnel to fill the powder into the bottle if so required.
- Caps loaded in the Vibrator Bowl are transferred to the Chute and at the end of the Chute, it is transferred to the star plate and further picked up by the capping head for Screw Capping operation to seal the cap on the bottle mouth.
PARTICIPANTS LOG:
All persons involved in the execution of this protocol must sign
INSTALLATION QUALIFICATION CHECKLIST:
| Checks to be performed |
| Check for the Dimensional accuracy |
| Check for the receipt of the consignment in good condition |
| Check for the Motor and the Gearbox |
| Check for the alignment of the drive |
| Check for the condition of the electrical panel. |
The purpose of this checklist is to check and document the receipt of equipment and spares as per the Purchase order.
SUBCOMPONENT CHECKLIST:
| Component (Make + Specs.) | Observation |
| MAIN MOTOR MAKE : BONFIGLIOLI 2HP/1.5KW/3.35A/415V/1430RPM/3PHASE SRNO.02210010287793008 | |
| FILLING CONVEYOR MOTOR MAKE : BONFIGLIOLI 0.25HP/0.18KW/1.01A/230V/1360RPM/3PHASE SRNO.201080448156 | |
| CAPPING CONVEYOR MOTOR MAKE : BONFIGLIOLI 0.25HP/0.18KW/1.01A/230V/1360RPM/3PHASE SRNO.210380523564 | |
| VIBRATOR MOTOR MAKE : CROMPTON 0.5HP/0.37KW/1.5A/230V/2815 RPM/3PHASE SRNO.SEBM 9749 | |
| VACUUM MOTOR MAKE : CROMPTON 3HP/2.2KW/4.84A/415V/1445RPM/3PHASE SRNO.UDGM 19385 | |
| INPUT GEAR BOX MAKE : BONFIGLIOLI MODEL : VF44 F120 P63 B5B3 SRNO.12 B03202665599 RATIO : 20:01 | |
| MAIN GEAR BOX MAKE : BONFIGLIOLI MODEL :W86 UF1 46 P100 B5B3 SRNO.190000091882910002 RATIO : 46:01 | |
| OUTPUT GEAR BOX MAKE : BONFIGLIOLI MODEL : VF44 F120 P63 B5B3 SRNO.07 B03202414716 RATIO : 20:01 | |
| MAIN A.C DRIVE MAKE : ALLEN BRADLEY MODEL : 22F-D4P2N103 SRNO.FD4P2NOW21130330 2HP/3.35A/415V/3PHASE | |
| FILLING CONVEYOR A.C DRIVE MAKE : ALLEN BRADLEY MODEL : 22F-A2P5N103 SRNO.FA2P5NOW20400018 0.5HP/2.5A/230V/3PHASE | |
| CAPPING CONVEYOR A.C DRIVE MAKE : ALLEN BRADLEY MODEL : 22F-A2P5N104 SRNO.FA2P5NOW20430067 0.5HP/2.5A/230V/3PHASE | |
| VIBRATOR MOTOR A.C DRIVE MAKE : ALLEN BRADLEY MODEL : 22F-A2P5N103 SRNO.FA2P5NOW20350225 0.5HP/2.5A/230V/3PHASE | |
| AIR SWITCH MAKE : DANFOSS | |
| PRESSURE GUAGE-1 MAKE : POINTER SRNO.PIPL-21012277 | |
| PRESSURE GUAGE-2 MAKE : POINTER SRNO.PIPL-19063874 | |
| PRESSURE GUAGE-3 MAKE : POINTER SRNO.PIPL-20111008 | |
| PRESSURE REGULATOR-02 NOS MAKE : SMC | |
| PRESSURE SWITCH MAKE : INDFOS MODEL : PSM-550 SRNO.9S00Q4D6 | |
| SOLENOID VALVE MAKE : SMC MODEL : SY5120-5L-01-F2 | |
| CAP FEEDING PISTON MAKE : SMC MODEL : C85N10-10 | |
| SOLENOID VALVE-02 NOS MAKE : FESTO MODEL : MFH-3-1/4 | |
| VACUUM PUMP MAKE : INDOVAC MODEL: IVS-1000 SRNO.21059980 | |
| MCB-1 MAKE : SCHNEIDER MODEL:A9N4P25C TYPE : 4P-25A | |
| MCB-2 MAKE : SCHNEIDER MODEL:A9N3P10C TYPE : 3P-10A | |
| MCB-3 MAKE : SCHNEIDER MODEL:A9N2P20C TYPE : 2P-20A | |
| MCB-4 MAKE : SCHNEIDER MODEL:A9N2P10C TYPE : 2P-10A | |
| CONTACTOR-1 MAKE : SCHNEIDER MODEL : LC1D25M7 TYPE : 25A | |
| CONTACTOR-2 -02 NOS. MAKE : SCHNEIDER MODEL : LC1D09M7 TYPE : 09A | |
| OLR-1 MAKE : SCHNEIDER MODEL : LRD10 4-6A | |
| OLR-2 MAKE : SCHNEIDER MODEL : LRD14 7-10A | |
| NO BOTTLE SENSOR MAKE : WENGLOR MODEL : P1KT002 TYPE : PHOTO ELECTRIC | |
| JAMMING SENSOR MAKE : WENGLOR MODEL : P1KT002 TYPE : PHOTO ELECTRIC | |
| SPINDLE JAM SENOSR MAKE : PANASONIC MODEL:EX-14A-PN TYPE : PHOTO ELCTRIC | |
| NO CAP SENSOR MAKE : PANASONIC MODEL : EX-14A-PN TYPE : PHOTO ELECTRIC | |
| NO BOTTOLE/NO CAP SENSOR MAKE : PANASONIC MODEL : EX-14A-PN TYPE : PHOTO ELECTRIC | |
| NO BOTTLE NO CAP GAP SENSOR MAKE : PANASONIC MODEL : PM-K45-PN TYPE : PHOTO ELECTRIC | |
| DOSSING SENSOR MAKE : LEUZE MODEL : 12MM TYPE : METAL PROXY | |
| PURZZING SENSOR MAKE : LEUZE MODEL : 12MM TYPE : METAL PROXY | |
| RESET COUNTER SENSOR MAKE : LEUZE MODEL : 12MM TYPE : METAL PROXY | |
| POWDER LEVEL SENSOR MAKE : LEUZE MODEL : 30MM TYPE : PROXY | |
| SMPS MAKE : DELTA MODEL:PMT-24V100W2BA SRNO.P624100BA020170846 | |
| HMI MAKE : DELTA MODEL : DOP-107CV SRNO.107CV006W21021383 | |
| PLC MAKE : DELTA MODEL : DVP-12SA211T SNO.12SA211TW19350286 | |
| MODULE MAKE : DELTA MODEL : DVP16SP11T SRNO.16SP11TOW20360981 | |
| SSR-03NOS. MAKE : PARAMOUNT | |
| RELAY MODEL : 8 CHANNEL TYPE : JUMPER TYPE |
COMPONENT LOCATION LIST:
| Component | Location | Observation |
| Drive Motor | Bottom of the machine | |
| Gear box | Bottom of the machine | |
| Drive Shaft Housing | Centre of the main body | |
| Filling Head | Machine Top Plate on L.H. side | |
| Screw Capping Head | Machine Top Plate on R.H. Side |
MOC VERIFICATION LIST: (REFERENCE TO CERTIFICATES):
| Sr. No. | Component | MOC | Observation |
| 1. | Machine frame structure | M.S. Angle- powder coated | |
| 2. | Door Set | S.S 304, (NO PAINTED SURFACE) | |
| 3. | Conveyor Belt | Delrin | |
| 4. | Conveyor Chain | U.H.M.W. (Nylon) | |
| 5. | Feed Worm | Nylon | |
| 6. | All Shafts | M.S. & S.S. | |
| 7. | Chain wheel for Conveyor | Nylocast. | |
| 8. | Chain wheel | M.S. | |
| 9. | Chain | Rollon Make, ½” Pitch. | |
| 10. | Column | M.S. duly ground and hard-chrome plated | |
| 11. | Column Housing | C.I. | |
| 12. | All Bearing (Make) | Imported | |
| 13. | All Oil Seal | Pioneer Make. |
TEST / INSPECTION REPORTS:
| Documents | Type |
| Motor | Test Certificate |
| Gear Box | Test Certificate |
| A.C. Drive | Test Certificates |
UTILITY VERIFICATION LIST:
| Sr. No. | Utility Parameter | Method of Verification | Acceptance Criteria | Observation | Checked By with Date | Remarks |
| 1 | Phase | Multi meter | 3 Phase | |||
| 2 | Voltage: | |||||
| 3 | Test 1 (Using Multi meter) | R V Y Y V B R V B | 415 ± 5% 415 ± 5% 415 ± 5% | |||
| 4 | Frequency | Multi meter | 50 Hz | |||
ATTACHMENT LOG:
All documents attached to this protocol should be listed in the following log. If the attachment is more than one page then denote the number of pages along with the protocol number, signature, and date on the first page of the attachment.
SUMMARY, CONCLUSIONS, AND RECOMMENDATIONS:
| Parameter | Comment (Yes / No/NA) |
| Did the IQ Protocol comply with all the parameters laid down in the document? | |
| Did the IQ invite any deviation? | |
| In case of any deviation, is it acceptable? |
ABBREVIATIONS:
Abbreviation | Expanded Form |
IQ | Installation Qualification |
| NA | Not Applicable |
| GMP | Good Manufacturing Practice |
| SS | Stainless Steel |
| RPM | Revolution Per Minute |
| HP | Horse Power |
| V | Volts |
| Hz | Hertz |
| A.C. | Alternating Currant |
| MOC | Material Of Construction |
POST EXECUTION APPROVAL
Approver’s signature
Approver’s signature indicates all the test mentioned in Protocol has been completed and all the amendment and discrepancies are documented approved attached to the protocol. The signature in the below blocks indicates that the qualification report has been reviewed and found to an acceptable state and all the discrepancies have been satisfactorily resolved.
