Small blister pack machine | 21 CFR Part 11 compliant

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EZ Blister+ is a 21 CFR part 11 compliant blister pack machine for pharmaceutical companies that require low volumes

The Sepha EZ Blister+ is a small blister pack machine, ideal for packaging tablets, capsules, ampoules, and other products.

Increasing market demand for packaging of high-value product in low-volumes has driven a need for equipment capable of producing blister packs whilst enabling you to be 21 CFR Part 11 compliant. The EZ Blister+ is a small blister pack machine that meets the need for electronic data storage capabilities and digital connectivity. It provides the same proven blister packaging performance, but with added software capabilities that enable the creation of electronic signatures, batch reports, audit trails and other electronic documentation.

The Sepha EZ Blister+ offers a 3-in-1 manufacturing process for low volume blister packaging including forming, sealing and perforating/cutting.

Pre-heating & Thermoforming / Coldforming
Pre-cut sheets are pre-heated to enable thermoforming. Aluminium sheets can be coldformed directly.
Filling & Sealing
The formed trays are sealed with pre-cut pieces of the preferred lidding material using knurled or flat heat-sealing
plates. Product traceability can be achieved by choosing the option of code embossing the lidding material.
Perforating & Cutting
The sealed trays are perforated if required and cut using a precision die cutter.

The table top blister packaging machine can help departments involved with clinical trials, stability studies, specialist drugs or packaging development as it’s designed to create small batches. The Sepha EZ Blister+ eliminates the need to interrupt busy schedules of Production departments, saving time and money. It also gives more freedom to plan and budget smaller projects as and when required.

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Features
- Full 21 CFR Part 11 capabilities
- Electronic signatures, batch reports, audit trails and other electronic documentation
- Cost-effective, high performance low volume blister packaging
- Ideal for packaging tablets, capsules, medical devices and other products
- Coldforming & thermoforming capability
- Tool-less changeover of format parts in less than 2 minutes
- Operating speed of approx. 200 cycles per hour for any single operation
- Customistable to individual commercial and manufacturing requirements
- Flexible and fast response to changes in customer demand
- Easy setup via HMI and minimal training required
- Compact space saving bench top design
- Precision engineered knurled or flat heat-sealing plates
- Perforated cutting tools (optional)
- Full database backup capabilities and disaster recovery management
- Unrivaled experience and knowledge in blister pack design
Technical Spec
- Pack Dimensions
  Max. format area: 180mm x 120mm / Max. thermoform depth: 14mm / Max. coldform depth: 12mm (Dependent on material type and cavity profile)
- Operation
- Construction
  Anodised aluminium, acrylic and polyurethane RIM moulded outer casing
- User Interface
  10.1″ PCAP touchscreen, flush-mounted modular push buttons
- Controls
  Temperature: 0 – 200°C* settable ±1 °C / Pressure: 0.2 – 0.6 MPa (Force: 6.3 – 18.8 kN) / Timers: 0 – 99.9 sec settable ±0.1 sec
- Utilities
  Electrical: Min. 110V Single phase, 15A, Min. 230V Single phase, 6.5A / Air: Min. 250L/min at 0.6Mpa [ISO8573-1:2010 CLASS 2]
- Connectivity
  Active directory, network printing, central network storage, custom data MES/OPC connectors available
* 250°C possible with high temperature sealing tool available on request
- Rear Ports / Switches
  3x USB, 2x ethernet port, LOTO fused isolator, 2x 8mm pneumatic push-fit connectors (Supply & Drain)
- Audit compliance
  Can be run in compliance with 21 CFR Part 11
- Operating Speed
  Approx. 200 cycles per hour for any single operation
- Tooling Changeover
  2-3 minutes
- Tooling Warm-up
  Approx. 10-15 minutes
- Machine Dimensions
  645mm (L) x 525mm (W) x 576mm (H)
- Weight
  Machine: 136kg / Tooling: 12kg / Shipping: 200kg (incl. tooling)
- Warranty
  Supplied with a 12-month warranty. (Extended warranties are available for additional support).
Application
The Sepha EZ Blister+ is ideal for producing small batches of high quality blister packs in:

Pharmaceutical Research and Development laboratories
- Clinical trials
- Stability studies
- Package development
- Marketing samples
Pharmaceutical production and packaging departments

Low volumes which may not normally be economic on high speed fully automatic lines can be turned around quickly on the Sepha EZ Blister+, e.g. packing small batches of specialist drugs.
Benefits
More control for R&D labs
- Bring your blister packing in-house instead of booking time on production lines or outsourcing to a third party – minimises delays, allowing your new drug product to get to market sooner
- Every day saved in the R&D lab is a day of extra profits in the marketplace
Flexible pack design
- Blister pack using a variety of materials, novel shapes, sizes or perforations – allows the full range of possibilities to be explored for pack development in the R&D lab
- Offers increased flexibility to contract packers
High quality blisters
- Reproducible, production quality packaging
- Fast & easy set-up – no specialist knowledge is required to operate the Sepha EZ Blister+ so there is no need for an engineer to be present
Compact, portable design

Table top design for convenient blister packaging

Reduce R&D time
- Sepha can design your new blister packs. This is especially useful for customers who conduct clinical trials. We can advise them how to rationalise the number of different tools needed, even if the lab needs to package many different products
More economical for batches up to 20,000 units
- Fully cGMP compliant, so it is quick to clean – requires 5 minutes
- Fast 2-minute changeover – reduces down-time between production batches