Editor’s Note:
In the pharmaceutical packaging field, patient safety and product quality are always our uncompromising top priorities. To ensure that the blister packaging process continuously complies with the strictest GMP (Good Manufacturing Practice) standards and comprehensively prevents production risks, we have compiled the Standard Operating Procedure for Blister Packaging for users’ reference. Since we are equipment manufacturers rather than GMP experts, please feel free to correct us if there is any inappropriateness in the content. Below are the core SOP highlights:
1. Purpose
This procedure aims to standardize the operation process of the blister packaging station and strictly prevent errors, contamination, and mix-ups during operations.
2. Scope
This procedure applies to all operations at the blister station within the blister packaging workshop.
3. Core Operating Procedures
3.1 Pre-Packaging Confirmation
* Personnel and Environment Control: Before entering the operating room, strictly check the number of people to ensure it does not exceed the maximum allowable limit. Confirm and record that the room pressure differential, temperature, and humidity are within the specified process range. If not up to standard, notify the engineering department for maintenance; check twice a day or per batch (once before starting and once after finishing).
* Room Clearance: Confirm that the operating room has been cleared and is within its validity period, attach the clearance certificate issued by QA to the production record, and change the status tag to “In Production”.
* Equipment Status: Confirm the equipment is cleaned and switch the status to “Running”. Check that compressed air and chilled water meet requirements. Confirm that the air pressure gauge is calibrated and that the equipment is within its validation period. Start the equipment to confirm normal operation.
* Material and Document Verification: Verify that the received products to be packaged and materials exactly match the inner packaging instructions, ensuring no unrelated materials are on site. Confirm there are no unrelated documents on site and that the batch production record matches the instructions.
3.2 Pre-Packaging Preparation
* Molds and Tools: If mold replacement is needed, collect them according to regulations and transport/install them using a clean stainless steel cart. Prepare clean spoons within their validity period, along with PE bags, material labels, and cable ties.
* Material Handover: Carefully verify inner packaging materials (name, incoming batch number, specifications, weight, and packaging integrity) with the temporary storage manager and sign for handover. Verify the intermediate product information and the green “Qualified” tag at the intermediate station, and transfer them to the packaging room upon confirmation.
3.3 Blister Packaging Operations
* Mold Installation, Disinfection & Debugging: Sequentially install feeders, forming/heat-sealing/punching molds, and character blocks for “Batch Number” and “Expiry Date”. Wipe and disinfect the inner and outer surfaces of hoppers and other parts with 75% ethanol. Set parameters, have them double-checked by another operator, and start the heating program.
* Quality Testing: Debug the equipment until the blister board appearance is qualified (Standard: full blisters, no crushing, clear/even textures, no punctures, clear printing, flat punching, and even edge spacing). After successful debugging, a sealing test must be performed. Formal production can only start after confirmation by workshop technical management and QA, and blank blister boards must be kept as samples.
* Formal Production (Offline/Inline): Continuously check the appearance of the blister boards during production to ensure no missing pills/pieces or other defects. Promptly apply labels with specified information once a bag is full. Unqualified boards must be promptly collected into the “Reject” container. Check the equipment’s automatic rejection function at the start and end of each day.
3.4 Post-Production Processing
* Material Inventory & Waste Disposal: Conduct material handover, verification, and signing after packaging. Pills or capsules in unqualified blister boards must be destroyed, placed in PE bags with a “Waste Label,” and disposed of according to regulations. Remaining inner packaging materials must be weighed and returned or carried over to the next batch.
* Clearance Management: Change equipment and room status tags to “To Be Cleaned” and “To Be Cleared” respectively. Perform cleaning and clearance in accordance with regulations, and hang the “Cleared and Ready” tag after passing QA inspection.
* Records & Data Integrity: Promptly fill out batch production records and calculate material balance and yield. Copy electronic records using a dedicated USB drive, print, sign for confirmation, attach to the batch record, and back up data per the Data Integrity Management SOP.
3.5 Handling Abnormalities
* Equipment Failure: Immediately cut power, securely seal and store materials from the hopper, protect equipment parts with PE bags, hang an “Under Repair” tag, and report for maintenance. After repair, thorough cleaning and 75% ethanol disinfection must be performed before resuming production.
* Sealing Misalignment: Stop feeding and shut down, remove affected materials, and resume production only after successful debugging.
* Yield Out of Limits: If material balance or yield exceeds limits, the batch of intermediate products must absolutely not be transferred for use; it must be immediately reported to the workshop head and QA for handling according to regulations.
4. Key Safety and Precautions
* Sealing Test Frequency: The sealing of blister boards must be sampled and tested at the start of daily production, end of production, and after any equipment reheating.
* Operational Safety: During equipment operation, it is strictly forbidden to arbitrarily open safety doors or touch heating and punching components with your hands. The machine must be completely stopped when replacing aluminum foil.
* Site Management: Pay attention to splices when changing packaging materials and watch out for sealing misalignment. Tools are strictly prohibited from being placed on the equipment table. If the weighing printout fails to automatically print the scale ID, it must be filled in.