DECARTONING OF AMPOULES [PICTORIAL]

1. Basic Concept

• Manual decartoning
  Operators open cartons and remove ampoules by hand, placing them into SS trays/baskets.
• Decartoning machine
  Automated or semi-automatic equipment that feeds, opens, and unloads ampoules from cartons/trays with minimal manual handling.

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2. Comparison Table

Aspect	Manual Decartoning	Decartoning Machine
Manpower requirement	High – multiple operators needed for big batches	Low – 1–2 operators to load, monitor, and unload
Speed / Throughput	Moderate, depends on operator skill & fatigue	High, consistent output (good for large-scale filling)
Consistency	Variable – human dependent	Highly consistent, repeatable cycle
Breakage risk	Higher – human handling, fatigue, slips	Lower if well-designed; uniform movements
Glass particle risk	Higher if handling is rough or careless	Lower; controlled motion, less shock to ampoules
Mix-up risk	Higher if multiple products handled in same area	Lower – usually dedicated settings/product per run
Contamination risk	More hand contact, more chances of poor technique	Reduced direct handling; easier to maintain routine
Traceability	Relies on manual log entries & tray labeling	Often better – can integrate counting / sensors / print
Ergonomics	Risk of strain (repetitive movements, bending)	Better – operators mostly supervise & load/unload
Flexibility	Very flexible – easy to change ampoule size/pack	Less flexible – change parts/adjustment may be needed
Learning / Training	Simple – short training period	More technical – training on settings, alarms, safety
Equipment cost (CAPEX)	Very low – just tables, trays, cutters	High – dedicated decartoning equipment
Running cost (OPEX)	Higher labour cost; minimal maintenance	Lower labour cost; higher maintenance & spare parts
Space requirement	Small area – table + trays	Larger footprint – machine + conveyor / infeed area
Cleaning & changeover	Simple – wipe tables, clean trays manually	Scheduled cleaning & change parts; more formalized
Qualification effort	Mainly procedural (SOP)	Full IQ/OQ/PQ of machine, alarms, safety, interlocks
Best suited for	Small/medium batches, low automation plants	Medium/large batches, high-speed filling lines

3. When to Prefer Manual Decartoning

• Small or low-volume batches
• Many product/ampoule sizes with frequent changeovers
• Plants where CAPEX is limited
• Backup / contingency when machine is down
• Early phase / development batches where process is still evolving

4. When to Prefer a Decartoning Machine

• High-volume commercial production
• Multiple shifts with tight timelines
• Need to reduce glass breakage and particle load before washing/sterilization
• Targeting lower manpower and improved ergonomics
• Strong focus on automation, counting accuracy, and traceability

MANUAL DECARTONING OF AMPOULES

5.1 Purpose

To describe the procedure for manual decartoning of ampoules in a controlled manner to prevent mix-ups, breakages and contamination.

5.2 Scope

This procedure applies to all ampoule packs received in cartons for use in sterile/aseptic filling in __________________ Department.

5.3 Responsibilities

• Production Operator:
  • Perform manual decartoning as per this SOP.
  • Ensure correct identification and segregation of good/rejected ampoules.
• Production Supervisor:
  • Verify decartoned quantity, reconciliation and labeling.
• QA Officer:
  • Perform line clearance and in-process checks as applicable.

5.4 Procedure

5.4.1 Pre-requisites

1. Ensure line clearance of the decartoning area is carried out and documented as per line clearance SOP.
2. Verify that the following are available and clean:
   • Decartoning table
   • SS trays / perforated baskets
   • Labeled containers for rejected/broken ampoules
   • Status labels (e.g. “UNDER PROCESS”, “REJECTED”)
3. Confirm product details (Product name, Batch No., Strength/volume, ampoule size) against:
   • Dispensing slip / material issue note
   • Carton label
4. Record starting details in Decartoning Log / BMR.

5.4.2 Manual Decartoning Steps

1. Bring the required number of cartons to the decartoning table as per material movement SOP.
2. Handle one product and one batch at a time.
3. Open each carton carefully using a safety cutter or scissors, avoiding contact with ampoules.
4. Remove inner trays/liners containing ampoules and place them gently on the table.
5. Lift ampoules manually from the tray and place them upright into clean SS trays or baskets.
6. Avoid knocking ampoules against each other or the tray edges to minimize breakage and glass particles.
7. Visually inspect ampoules during transfer for:
   • Broken or cracked ampoules
   • Chipped necks or tips
   • Major printing or glass defects
8. Segregate any defective ampoules into the “REJECTED/BROKEN” container.
9. Continue until the required quantity for the batch is decartoned.

5.4.3 Post-Decartoning

1. Count and record:
   • Total ampoules received
   • Total ampoules decartoned
   • Total rejected/broken
2. Ensure reconciliation is within defined limits as per BMR.
3. Label each tray/basket of decartoned ampoules with:
   • Product name
   • Strength/volume
   • Batch No. / Lot No.
   • Quantity
   • Date and time of decartoning
   • Operator initials
4. Apply appropriate status label (e.g. “TO BE WASHED”).
5. Transfer the trays of ampoules to the next stage (e.g. washing) as per material handling SOP.
6. Dispose of broken ampoules and glass waste as per glass waste disposal SOP.

5.5 In-Process Checks (Manual)

• Correct product/batch and ampoule size in use
• Decartoning area free from any other product
• Adequate labeling of trays and reject containers
• Reconciliation of good vs. rejected ampoules acceptable

5.6 Acceptance Criteria (Manual)

• No evidence of product mix-up.
• Glass breakage maintained within historical/validated limits.
• All trays properly labeled and traceable.
• All rejects recorded and disposed as per SOP.

6.0 DECARTONING OF AMPOULES USING DECARTONING MACHINE

6.1 Purpose

To describe the procedure for decartoning ampoules using an automatic/semi-automatic decartoning machine, ensuring controlled, efficient and low-breakage handling.

6.2 Scope

This procedure applies to all ampoule cartons processed through the Decartoning Machine (Equipment ID: _______) in __________________ Department.

6.3 Responsibilities

• Machine Operator (Production):
  • Set up, operate and monitor the decartoning machine as per this SOP and equipment manual.
• Production Supervisor:
  • Verify settings, output quantity and reconciliation.
• Engineering:
  • Ensure availability and upkeep of machine (PM, breakdown support).
• QA:
  • Line clearance, periodic audit and verification of process controls.

6.4 Procedure

6.4.1 Pre-requisites

1. Ensure decartoning machine has undergone cleaning and line clearance for the new product/batch as per SOP.
2. Confirm that change parts (if any) are installed for the specific ampoule size and carton type.
3. Check that safety guards, interlocks and emergency stop are functional.
4. Verify product details (Product, Batch, Strength, ampoule size) against BMR and carton labels.
5. Record machine ID, product name, batch number, and starting carton count in Decartoning Log / BMR.

6.4.2 Machine Set-up

1. Start the machine as per manufacturer’s Start-up procedure.
2. Set parameters as applicable (e.g. conveyor speed, feed rate).
3. Run the machine empty for a short time to check abnormal noise or vibration.
4. Load a trial carton and observe:
   • Carton feeding
   • Opening/tearing mechanism
   • Ampoule unloading path
   • Discharge of decartoned ampoules into trays or conveyor
5. Ensure ampoules are not falling from excessive height or colliding excessively.

6.4.3 Routine Operation

1. Load cartons onto the machine in-feed as per defined loading pattern.
2. Operate the machine within qualified speed range.
3. Collect decartoned ampoules from the machine discharge into SS trays/baskets provided.
4. Periodically perform visual inspection at discharge for:
   • Broken or cracked ampoules
   • Misaligned or jammed ampoules
   • Carton pieces or foreign matter mixed with ampoules
5. Remove broken ampoules and place them into “REJECTED/BROKEN” container.
6. Monitor machine alarms / stoppages and inform Engineering in case of any recurring issues.

6.4.4 In-Process Checks (Machine)

Perform and record the following at defined frequency (e.g. start, every ___ minutes, and end):

• Count of ampoules per sample tray vs. machine counter (if available).
• Visual breakage rate: number of broken ampoules during defined interval.
• Confirmation that only one product/batch is being decartoned.
• Check that no carton pieces remain mixed with decartoned ampoules.

6.4.5 Post-Decartoning

1. Stop machine as per standard shutdown procedure.
2. Complete quantity reconciliation:
   • Cartons loaded / ampoules expected
   • Ampoules obtained
   • Rejected/broken ampoules
3. Label trays/baskets of decartoned ampoules with:
   • Product name
   • Strength/volume
   • Batch/Lot No.
   • Quantity
   • Date/time of decartoning
   • Operator initials
4. Apply status label (e.g. “TO BE WASHED”).
5. Remove residual ampoules, cartons and dust from the machine as per cleaning SOP.
6. Dispose of broken ampoules and carton waste as per waste management SOP.

6.5 Acceptance Criteria (Machine)

• Machine operated within qualified speed and parameters.
• Breakage rate within validated limits and not higher than defined target.
• No mix-up of product, batch or ampoule size.
• Reconciliation between input (cartons) and output (ampoules + rejects) is within defined limits.
• All trays of decartoned ampoules are correctly labeled and traceable.
• No carton fragments or foreign matter present in decartoned ampoules.