CLEANING, OPERATION, PRECAUTIONS & MONITORING OF AUTOMATIC STICKER LABELING MACHINE

CLEANING, OPERATION, PRECAUTIONS & MONITORING OF AUTOMATIC STICKER LABELING MACHINE

PURPOSE : To provide written procedure for cleaning, operation, precaution & monitoring of automatic sticker labeling machine.

SCOPE : This SOP shall be applicable for cleaning, operation, and precaution & monitoring of automatic sticker labeling machine at SVP section.

REFERENCE(S)

Operating Instructions manual of labeling machine

CROSS REFERENCE DOCUMENTS

Document(s) and Data Control Procedure

Training Program & management Preparation, review, approval, issuance & retrieval of standard operating procedure (sops)

DEFINITIONS

Labeling: Labeling is a part of branding & enables product identification. It is printed information that is bonded to the product for recognition & provide detail information about the product.

Drug labeling also referred to as prescription labeling, it is a printed, written or graphic matter upon any drug or any of its container or accompanying such a drug. Drug label seeks to identify drug contents & to state specific instructions or warning for administration, storage & disposal.

ABBREVIATIONS

cGMP : Current Good Manufacturing Practice

SVP : Small Volume Parenteral

EHS : Environment, health & safety

IPA : Isopropyl Alcohol

PLC : Programmable Logic Control

BPR : Batch Packing Record

RESPONSIBILITY

Operator shall be responsible:

Operator shall be responsible for cleaning & operation of labeling machine.

Operator shall be responsible for line clearance.

Originating department supervisor/officer/designee shall be responsible:

Preparation of the SOPs.

To provide the final draft copy to Quality Assurance.

To perform the line clearance.

To maintain the cleaning & operation record of sticker labeling machine.

To provide the training of the SOP to concerned personal before effective date of SOPs.

Head of Originating department/designee shall be responsible for:

Checking of the SOP for procedural, technical content, accuracy and cGMP compliance.

To get the SOP approval from Head Quality Assurance or designee.

After training user department Head or designee to ensure implementation of the SOP on effective date.

To maintain the controlled copies of the SOPs at required location.

To ensure the compliance of SOP.

Quality Assurance department shall be responsible for:

To checking of the draft SOP for technical, function, regulatory and cGMP compliance prospective.

To maintain the approved master copy of the SOP of all department for document control.

To verify that all the instructions are followed properly as per the given SOP.

To verify all the equipment related documents & records.

To ensure implementation of SOP.

To provide the line clearance.

Head – Quality Assurance/ Designee shall be responsible for:

To approve new or revised SOP.

Review of draft SOP for technical, function, regulatory and cGMP compliance.

Final approval of the SOP by signing off as approved by.

To ensure the implementation of the defined system.  

Engineering person shall be responsible for:

To provide all required utilities for operation of machine.

Perform maintenance of system as per respective SOP.

Co-ordinate with production person for schedule preventive maintenance of equipment.

Plant Head shall be responsible for:

To approve new or revised SOP.

To ensure the implementation of the defined system.

PROCEDURE:

SAFETY/PRECAUTION/EHS

Switch off the machine during cleaning & maintenance activities.

Don’t spray IPA directly on electrical part of the machine.

Always remove the sticky labels from the conveyer belt to avoid accumulation.

Always use trained operator to run the machine to avoid any mis-happening.

Operation

Check the status of machine for its operation.

Visually check the machine & its surrounding area for cleanliness.

Visually check there is no material of previous batch/product is there.

Maintain the status label of machine.

Get the line clearance from production/quality assurance person before start the labeling operation.

Issue the sticker label roll from secondary packing material store.

Switch “ON” the main power supply of the labeling machine.

Switch “ON” the control panel of labeling machine.

Set the label roll on label spool shaft of dancing roll assembly.

Arrange the roll on the labeling machine as per flow diagram on dispenser body.

Adjust the release plate with nylon brush as per the ampoule cassettes size.

Press “MAN” button on the control panel & then press “INCHING” to adjust the label as per label sensor.

Press again “MAN” button to auto detect the label length. To avoid double dispense at a time, enter proper label length value. Label length = Actual label length+gap+2mm.

Press “ENT” to adjust the pre-dispensing of the label. it can be even change by shifting position of label sensor or by changing the value in programmer.

Now press “ENT” to set the product delay, it is a delay time product sensor. If the label stick on the cassette before its position or it dispense before, then decrease the delay value with down ward arrow key. If label stick on cassette after the position, then increase the delay value with upward arrow key.

Then press “ENT” to adjust the conveyer belt speed.

Adjust the product sensor with set screw provided manually as per ampoules cassettes height, it sense the presence of ampoules cassettes. It is a “retro reflective type               sensor” where reflector has to be in front of sensor & when ampoule cassette passes between sensor & reflector it gives signal through PLC to dispense motor & yellow light gets “ON”.

Adjust the guide of conveyer belt as per cassettes width, so that cassettes doesn’t motion zig zag during travelling on conveyer belt.

After adjustment of label press “START” button control panel & conveyer belt will start running.

Press “RUN” to start the label dispenser, then arrange the ampoules cassettes on the conveyer belt of labeling & start labeling, check the label  for proper position on the ampoules, without defect pasting or tilting of label or any other defect.

If any defects observe then rectify with the keys as follows in provided on the control panel.

After proper adjustment of label roll, run the machine, production & QA person will verify the labelled ampoules to check labeling accuracy.

Online counter will count the labeled ampoules quantity.

After finish of one roll, stop the machine & repeat the same process to adjust another roll & reset the counter by pressing “TOG” key on the control panel & repeat the same  to run the machine.

After completion of labeling/end of batch, press “ESC” key to stop the labeling & then press “STOP” key to stop the conveyer of the machine.

After completion of batch quantity check the online counter on panel & remove the remaining roll (if any) & prepare the machine for further batch.

Make entry in the BPR & concerned log book.

Cleaning

Remove all rejected ampoules, labels from the machine.

Clean the conveyer belt & outer body of the machine with IPA 70% v/v solution.

Clean the control panel of machine with dry lint free cloth.

Cleaning should be perform at start or end of the batch, at the time of changeover.

After proper cleaning after getting line clearance from QA the further process will be start.

Maintenance

Maintenance of labeling machine to be performed by trained operator during on schedule basis.

Daily check the roller on label dispensing unit & label release edge are clean & free of Labels, label adhesive & colour particles.

Daily check all label web guide rollers & product guide.

Weekly check the surface of rollers of product conveyer, is it clean or not.

Weekly check the tightness of bolt & nuts to avoid misalignment or accident.

Monthly check the pneumatics & electrical part of machine.

Monthly check the oil level of gear box.

Monthly check the endless belt, timing belt for tension & sign of wear & replace it if damage.