PBL-400S-400SF · Integrated pharmaceutical packaging line
Form PVC/ALU trays, load glass products by robot, inspect, seal, punch, fold the leaflet and carton on one coordinated line. HIJ configures the machine around the approved product, tray, carton, accepted-output target and FAT protocol.
Choose the correct configuration first
The PBL-400S-400SF is most useful when the product needs a formed tray and the buyer wants primary-pack and secondary-pack handling managed as one project. It is not automatically the best answer for every blister or carton.
Important: 8,000 pcs/h is the project basis in the supplied technical file. Final accepted output must be agreed against the actual syringe or ampoule, packaging materials, inspection scope and FAT conditions.
Real machine stations
Select a station to enlarge it. The caption stays with the image so a buyer can connect each machine view to a scope decision.
Coordinated process
The line is one sequence, but every station needs its own method, limit and retained evidence. That is what makes two quotations comparable.
Guide and preheat the PVC web, form the approved tray geometry and monitor material availability.
Receive labeled syringes or ampoules, buffer the upstream interface and present products for robotic pick-up.
Place products into formed trays, detect loading status and segregate defined defects.
Apply the approved lidding web and demonstrate an operating window that protects product and pack.
Cut the finished cards, manage scrap and transfer accepted blisters toward the cartoner.
Pick one leaflet, create the approved fold and synchronize delivery with the blister and carton.
Open the carton, insert leaflet and blister, apply batch coding and close the carton.
Challenge defined defects, confirm reject disposition and retain the agreed run and inspection evidence.
Verified technical baseline
These values come from the current HIJ technical file. Product-specific tooling, accepted output and final included functions remain subject to the approved quotation, drawings and FAT protocol.
| Specification | Current technical-file value | Buyer decision |
|---|---|---|
| Packaged products | Glass pre-filled syringes and glass ampoules | Provide drawings, orientation, fragility limits and representative samples. |
| Project output basis | 8,000 pcs/h | Convert the target into accepted packs per agreed sustained run. |
| Blister material basis | PVC/ALU; project PVC thickness 0.25–0.40 mm | Approve exact forming and lidding grades before trials. |
| Punching frequency | 10–30 times/min | Confirm cavities per stroke and finished-card layout. |
| Maximum forming area | 220 × 400 mm | Check usable area after trim, sealing and registration allowances. |
| Stroke range | 50–220 mm, servo adjusted | Confirm the format-specific stroke in the approved drawing. |
| Carton size range | 65–180 × 33–85 × 15–75 mm | Submit finished carton drawings and paper samples. |
| Leaflet size range | 60–190 × 90–260 mm; 60–75 g/m² paper basis | Confirm fold pattern, grain, print orientation and insertion direction. |
| Cartoning section maximum | Up to 300 cartons/min mechanical capacity | Do not treat this as accepted line output; final rate follows the full configured process. |
| Power supply / machine power | 380 V, 50 Hz / 35 kW | Verify destination voltage, frequency and site distribution. |
| Compressed air | 0.6–0.8 MPa; up to 500 L/min | Confirm pressure, quality, connection and available capacity. |
| Overall dimensions / weight | 14,000 × 2,500 × 2,000 mm / approximately 10,000 kg | Review access, floor, utilities, maintenance clearances and line interfaces. |
The maximum figures above are equipment-envelope values. A purchase specification should separately state rated mechanical capacity, target output and FAT accepted output.
Control and component boundary
The technical file identifies a Siemens CPU1516T PLC, Siemens servo axes, Yamaha robotic handling and a GUK C91 leaflet folder. Those brands matter, but the quotation also needs to define software functions, interfaces, alarms, recipes, access levels and the evidence used to accept them.
URS inputs
Product drawings, weight, glass details, plunger or needle features, orientation, allowable contact, incoming presentation and worst-case samples.
Tray drawing, cavities per card, forming web, lidding web, sealing method, artwork, registration, perforation and cut criteria.
Finished carton and leaflet drawings, paper grades, fold scheme, coding content, closure method and samples from the intended suppliers.
Required good packs per hour, shift pattern, changeover frequency, planned stops, reject accounting and agreed operating factor.
Upstream labeler discharge, buffers, downstream equipment, utility points, communication signals, room layout and access restrictions.
URS response, drawing approvals, document index, FAT protocol, challenge tests, sampling, data retention and site-support boundary.
Inspection and rejection
The technical file includes detection points for PVC availability, pressure, forming, tray loading, leaflet position, tray position, carton opening, pusher overload and motor protection. The FAT should define how each required function is challenged and what record is retained.
Challenge material shortage, incomplete forming and recovery after a controlled stop. Retain settings, samples and the defect log.
Challenge missing and mis-presented products. Confirm detection timing, reject path and disposition record.
Challenge low material, no leaflet and incorrect feed behavior. Confirm interlocks with carton suction and product push.
Challenge a carton jam or opening fault. Confirm alarm, stop behavior, access and restart method.
Verify the defined pusher and motor protection response without damaging product or machine.
Record total output, accepted cartons, rejects, waste, stops and interventions against the approved acceptance limits.
Acceptance evidence
| FAT decision | Method to approve | Evidence to retain |
|---|---|---|
| Web handling | Run approved lots through start, splice, normal operation and controlled stops. | Material identification, reel setup, tension settings, observations and deviations. |
| Forming repeatability | Measure the agreed cavity features from samples taken across the run. | Approved samples, settings, measurements, instruments and defect log. |
| Product loading | Challenge normal, missing and mis-presented products using the approved sample set. | Challenge list, detection results, reject confirmation and disposition. |
| Seal process | Run the approved web pair inside the agreed operating window and test the seal by the buyer-approved method. | Material lots, settings, sample plan, results and deviations. |
| Registration and cutting | Compare artwork, cut position and finished-card dimensions with approved drawings. | Measured samples, artwork controls, registration and cut records. |
| Cartoning sequence | Challenge product, leaflet and carton presence interlocks plus jam and restart behavior. | Test results, alarms, reject records, recovery observations and open items. |
| Accepted output | Run for the agreed duration under the agreed operating conditions. | Total output, accepted output, rejects, waste, stops and operator interventions. |
Equipment documentation supports the buyer’s qualification work. It does not replace the facility’s quality system, process validation, product release or regulatory assessment.
Configuration choice
| Decision | Integrated PBL-400S-400SF | Standalone blister machine and cartoner |
|---|---|---|
| Project boundary | One coordinated scope for forming, robotic loading, transfer, leaflet handling and cartoning. | Separate machine scopes plus an interface, buffer and responsibility matrix. |
| Product transfer | Designed around direct transfer between stations within the configured line. | Requires an agreed intermediate discharge, accumulation and infeed method. |
| Controls | Sequence, alarms and interlocks can be defined across the complete line. | Control handshakes and reject reconciliation must be defined between systems. |
| Flexibility | Best when the product family and pack route justify a dedicated integrated configuration. | Useful when machines must run independently or serve multiple upstream and downstream routes. |
| Acceptance | One end-to-end FAT can test the complete pack flow. | Machine FATs and line-interface acceptance may need separate protocols. |
Request a comparable quotation
HIJ can respond with a configuration, open-item list and FAT boundary after the product, materials, output and document scope are clear. This prevents a low base-machine number from hiding tooling, inspection, interface or qualification work.
Buyer questions
A blister cartoning machine inserts a finished blister pack and leaflet into a carton, closes the carton and applies the configured checks and coding. An integrated line such as the PBL-400S-400SF also forms the tray, loads the product, seals and punches the blister before cartoning.
The current HIJ technical file uses glass pre-filled syringes and glass ampoules as the product basis with PVC/ALU blister packaging. The final tooling and handling method must be approved against the buyer’s actual product drawings and samples.
The supplied technical file gives 8,000 pieces per hour as the project basis. It also lists up to 300 cartons per minute for the cartoning section, but that mechanical maximum is not the accepted output of the complete configured line. The contract and FAT should state good packs over an agreed sustained run.
The current file lists carton sizes of 65–180 × 33–85 × 15–75 mm and leaflet sizes of 60–190 × 90–260 mm. These are equipment ranges, not confirmation that every combination will run. HIJ must review the exact drawings, materials and fold pattern.
The technical file identifies a Siemens CPU1516T PLC, Siemens servo axes, Yamaha robotic transfer and a GUK C91 leaflet folder. The final component list and software functions should be frozen in the approved project documents because configurations can change.
The FAT should test the approved product and packaging materials, forming repeatability, product loading, seal process, registration and cutting, leaflet and carton interlocks, rejection, restart behavior and accepted output. The protocol should name acceptance limits, sampling and retained records before execution.
No. The equipment and supplier documents can support the buyer’s qualification and validation program, but they do not replace the buyer’s quality system, product-specific process validation, site qualification, regulatory assessment or release responsibilities.
Price depends on the product set, tooling, materials, feeder and interface scope, inspection, coding, data functions, documents, trials, destination and site services. Send the approved drawings, samples and acceptance requirements so HIJ can quote a comparable project boundary.
Continue your selection
PBL-400S-400SF project review
Send the product drawings, blister and carton materials, accepted-output target and FAT requirements. HIJ will review the configuration and identify the information still needed for a responsible quotation.
