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503B, hospital and repackaging pharmacies

Unit Dose Packaging Machines for Pharmacies

Mactec builds unit dose packaging machines for 503B outsourcing facilities, hospital pharmacies and repackagers. Package single doses as blister cards on the NanoXL or the MT Table Top Blister Sealer, as strip pouches on the MTVP100 and MTVP200, or in cups and vials on the MTMB24.

For a 503B outsourcing facility evaluating packaging equipment, start with the product, primary package, and closing method. Mactec’s blister, pouch, and rotary filling platforms provide different starting points for an application review.

Define the product and primary package

Describe the product to be filled or placed, the intended dose, and the package materials. For rigid containers, supply the container and closure together. For blisters or sachets, provide the proposed package drawing and sealing materials.

Choose the equipment family around the process

Separate equipment scope from process requirements

Identify your facility’s cleaning, product-handling, inspection, coding, and documentation requirements at the start of the discussion. Specify which operations and responsibilities must be included in the proposal. Mactec machine controls can be supplied to meet 21 CFR Part 11 requirements for electronic records and signatures, with user log-ins and an audit trail. Equipment selection alone does not establish regulatory compliance or sterile or aseptic suitability.

Questions for a 503B equipment review

Which platform should we evaluate first?

Use the primary package to narrow the choice: a formed blister, a flexible sachet, or a rigid container. The product and required closing operation then determine the configuration to evaluate.

Can one machine handle several products?

Provide the full proposed product and format list. Tooling, product-contact components, filling equipment, and cleaning requirements need to be reviewed for each application; compatibility should not be assumed.

What should be confirmed before ordering?

Agree on the equipment and options, representative materials, acceptance criteria, and the installation or documentation support included. Record any requirements that remain outside the equipment scope.

Review your packaging requirements

Tell Mactec which product and package you are planning, along with the operations and facility requirements that matter to your team.

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Project example

See related Mactec project work

Review factual project examples related to this equipment family or application, then discuss the requirements that make your project different.

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