OQ OF DRY SYRUP FILLING AND CAPPING MACHINE (MONOBLOCK)

OPERATIONAL  QUALIFICATION OF DRY SYRUP FILLING AND CAPPING MACHINE (MONOBLOCK)

Contents

• Pre Execution Approval
• Objectives of this Qualification Protocol
• Scope of this Qualification Protocol
• Acceptance Criteria
• Responsibilities
• Participant Log
• Documentation Identification
• Equipment Description
• Various Operational – n- Functionality Checks
• Steps involved in checking various interlocks
• Power & Failure & Restoration
• Attachment Log
• Recommendations
• Summary
• Abbreviations
• Post Execution Approval

PRE-EXECUTION APPROVAL

This approval is issued after successful completion of Installation qualification. Also this indicates to start Operational Qualification of Automatic Rotary Volumetric Dry syrup Filling with Pick & Place type Screw Capping Machine, Head: 16 x 8.

Prepared by:

The person is responsible for the accuracy and issue of this OQ Protocol.

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.

OBJECTIVES OF THIS QUALIFICATION PROTOCOL:

• To provide the guidelines for the Operational Qualification of the Automatic Rotary Volumetric Dry Syrup Filling with Pick & Place type Screw Capping Machine, Head: 16 x 8.
• To demonstrate that the equipment operates within its full range of operation.
• To document the initial performance of the equipment for future reference.

SCOPE OF THIS QUALIFICATION PROTOCOL:

• This Operational Qualification is applicable to Automatic Rotary Volumetric Dry Syrup Filling with Pick & Place type Screw Capping Machine Head: 16 x 8.
• This protocol defines the test procedures, documentation, references & acceptance criteria to establish that the Automatic Rotary Volumetric Dry Syrup Filling with Pick & Place type Screw Capping Machine, Head: 16 x 8 and performs in accordance with Design Qualification.

ACCEPTANCE CRITERIA;

• All Operating inputs provided on the equipment, when tested successfully, shall comply with their intended and shall comply with their intended use and meet the tolerance limit.
• All checks of operational qualification shall be found to be in accordance with Design Qualification.

RESPONSIBILITIES:

• The Production & the Engineering department should jointly carry the qualification.
• The Production and the Engineering team should evaluate the Protocols and Test results. Approval of the Protocol & its test results should be by Quality Assurance.

PARTICIPANT LOG:

All persons involved in the execution of this protocol must sign.

DOCUMENTATION IDENTIFICATION:

A copy of the necessary technical drawings should be available with this OQ Protocol. (Enter the details in the respective columns during the OQ exercise)

EQUIPMENT DESCRIPTION:

The Automatic Rotary Volumetric Dry Syrup Filling with Pick & Place type Screw Capping Machine, Head: 16 x 8 machine works on volumetric principle with Powder Wheel for filling pre-set powder volume in a bottle and subsequently Screw capping on the bottle.

Basic Constructional Features:

• The Unit is compact, versatile, and enclosed in S.S. elegantly hair finish body.
• SS 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 the 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 16 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.

VARIOUS OPERATIONAL – &- FUNCTIONALITY CHECKS:

STEPS INVOLVED IN CHECKING VARIOUS INTERLOCKS:

POWER FAILURE AND RESTORATION:

Start the machine in its standard starting procedure.

Trip the main incoming power supply, thereby simulating for Pseudo Power Failure.

Wait for some time and Switch ON the main incoming power supply.

Acceptance Criteria:

• The machine should not start until and unless it is started manually.

Observation:_____________________________________

Conclusion:______________________________________

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.

RECOMMENDATIONS:

SUMMARY:

Hand Written Summary:

ABBREVIATIONS:

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.