Primary plastic packaging for the pharmaceutical industry

We offer: • A range of standard pharmaceutical

primary packaging, such as snap-on bottles for spray pumps, eye-droppers, container bottles, caps, and Class I medical devices such as cups and spoons;

• The development and manufacture of tailor-made pharmaceutical plastic packaging solutions and Class I medical devices.

PlasticProgress Pharma Packaging is specialized in the manufacture of primary plastic packaging and Class I medical devices for the pharmaceutical industry.

We employ a fully monitored and documented quality assurance system, providing full traceability throughout the manufacturing process, from the raw materials used up to the delivery of our products.

We run an efficient manufacturing operation, with an innovative production layout and optimized procedures. Our injection-blow moulding and injection moulding machines incorporate proven technology in the manufacture of primary plastic packaging and Class I medical devices for the pharmaceutical industry.

We are certified to ISO 9001:2008 since October 2011, and to ISO 15378:2011 standards since April 2013.

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All our plastic primary packaging and Class I medical devices are manufactured according to Good Manufacturing Practices (GMP).

Our cleanroom is regularly audited and qualified to ISO Class 7, with a constant ISO Class 5 laminar flow in the moulding area, in full compliance with ISO 14644-1 standards. Our offer of standard and customized products meet your highest demands in safety, accuracy and functionality.

We are flexible in order to help you to deliver results - as your supplier, we are a reliable partner that ensures supply of your primary plastic packaging and Class I medical devices needs.

Our offer meets your highest demands in quality and safety:

• Focus in customer service;

• High functional quality products;

• Flexibility and capacity to adapt;

• Know-how and experience;

• Fulfilment of our engagements.

• 12ml, 20ml and 30ml snap-on bottles with S20 neck finish for spray pumps for nasal, ophthalmic, ear, buccal, throat or topical applications;

• 5ml, 10ml and 15ml dropper bottles with tamper-evident caps;

• 5ml spoons and 10ml, 20ml and 25 ml cups;

• 100ml and 150ml bottle containers for solid oral formulations, with 38mm screw-on caps, CR capsules, or snap-lock caps;

• 35ml bottle containers for moisture-sensitive solid formulations with desiccant capsules embedded in our tamper-evident caps.

Snap-On Bottles

• Rigid bottles produced in HDPE with injection-blow moulding technology for superior dimensional accuracy and quality;

• Produced in our qualified ISO Class 7 cleanroom, with ISO Class 5 laminar flow in the moulding area, in compliance with ISO 14644-1 standards;

• S20 neck finish qualified for use with Aero Pump, WestRock, Aptar (F-1299) and Coster (20MSP21) spray pump devices.

• Available range: 12ml, 20ml and 30ml bottles;

• 15ml bottle with Aptar F-1301 neck finish under development;

• Sealed and packed under validated packaging process according to ISO 11607-2 standards.

• Squeezable bottles produced in LDPE with injection-blow moulding technology for superior dimensional accuracy and quality;

• Cap with tamper-evident ring; • Produced and sealed in our qualified ISO Class 7 cleanroom, with ISO Class 5

laminar flow in the moulding area, in compliance with ISO 14644-1 standards.

• Available range: 5ml, 10ml, and 15ml bottles;

• 30ml bottles under development; • Sealed and packed under validated

packaging process according to ISO 11607-2 standards.

Dropper Bottles

Tablet & Capsule Containers

• Container bottles for solid oral formulations, produced in HDPE with injection-blow moulding technology for superior dimensional accuracy and quality;

• Screw-on and snap-lock caps with tear-off seal strip available according to your requirements;

• Bottles and caps manufactured in our ISO Class 7 cleanroom, with ISO Class 5 laminar flow in the moulding area, in compliance with ISO 14644-1 standards.

• Available range: 100ml and 150ml; • 200ml and 250ml bottles under

development; • CRC closures available; • Automatic assembly of foam liners,

induction heat seals and pressure-sensitive seals according to your needs.

• Container bottles for moisture-sensitive solid oral formulations, produced in HDPE with injection-blow moulding technology for superior dimensional accuracy and quality;

• Caps with tamper-evident ring, with embedded desiccant canisters with silica gel as a drying agent inside the cap.

• Available in 35ml capacity; • 20ml and 50ml capacities under

development; • Bottles and caps manufactured in our

ISO Class 7 cleanroom, with ISO Class 5 laminar flow in the moulding area, in compliance with ISO 14644-1 standards.

Moisture-Barrier Bottle Containers

Class I Medical Devices - Cups and Spoons

• 10ml, 20ml and 25 ml cups produced in food-grade PP polymer; • 5ml spoons available in food-grade PP or PS polymers; • Cups and spoons may be manufactured upon requirement in our ISO Class 7

cleanroom, with ISO Class 5 laminar flow in the moulding area, in compliance with ISO 14644-1 standards.

• Standard packaging in bulk, in double brace-sealed bags;

• Special packaging and bag sealing available according to your requirements.

Class I Medical Devices - Cups and Spoons with Measuring Function

• We have in place all the procedures to implement full compliance to Directive 93/42/EEC, Annex V, to apply the CE mark on your Class I Medical Devices; our certification is currently on hold.

• 5ml spoons and 25ml cups available with CE (0120) marking, once current certification is renewed;

• Produced and sealed in our ISO Class 7 cleanroom, with ISO Class 5 laminar flow in the moulding area, in compliance with ISO 14644-1 standards.

Development and Manufacturing Services

• We support the development and manufacture of bespoke primary plastic packaging solutions and Class I Medical Devices, from small pre-series manufacture up to high production volumes;

• Support is provided in product engineering, 3D prototype printing, and tooling manufacturing.

• Parts assembly performed according to your requirements;

• Manufacture, sealing and packaging in ISO Class 7 cleanroom compliant to ISO 14644-1 standards, with ISO Class 5 laminar flow in the moulding area.

Our modern injection-blow moulding machines allow us the manufacturing of snap-on bottles, dropper bottles, container bottles and vials with capacities from 5,0 ml up to 500 ml.

• State-of-the-art machinery;

• High capacity output and short injection cycles;

• Moulding finish with no plastic scrap;

• High dimensional accuracy in the neck finish;

• Minimal variations in weight, wall thickness, and volume.

We use injection moulding for the manufacture of caps and closures, Class I medical devices such as cups and spoons, and other plastic components, weighing from 1,0 g up to 2,0 kg.

• State-of-the-art machinery;

• Multiple capacity machines allowing for high production flexibility;

• Proven technology providing a reliable output.

Our state-of-the-art machines have cabins equipped with HEPA filters in the moulding area, which are kept under pressure with an ISO Class 5 laminar flow, feeding the cleanroom with encapsulated conveyor belts.

Our injection and injection-blow moulding machines are located outside our ISO Class 7 cleanroom, for added production efficiency and increased hygiene and safety of your products.

Our clean room facilities are under permanent surveillance for temperature, pressure and humidity levels, and documented records are kept for a period of 5 years.

The isolated moulding areas of the injection and blow-moulding machines and the encapsulated conveyor belts, are classified as ISO Class 5 and regularly audited, in full compliance with ISO 14644-1 standards.

All our primary plastic packaging and Class I Medical Devices are sealed and packed without direct human contact in our certified and regularly audited ISO Class 7 cleanroom, in full compliance with ISO 14644-1 standards.

- Packaging and sealing may be performed according to customer special requirements;

- A validated packaging process according to ISO 11607-2 standards is available for snap-on bottles and 3-part dropper bottles to be sterilized.

An assembly machine is available for the automatic in-line application of foam liners, induction-heat seals and pressure-sensitive seals, as well as for embedding desiccant capsules in our range of caps.

- Use foam liners to ensure tightness of your packaging, or induction-heat seals or pressure-sensitive seals for added tamper-evidence protection to your packaging;

- Use embedded desiccant capsules in the caps to protect your moisture-sensitive solid oral formulation products.

A product traceability system allows for documented, full batch histories for each production run. The traceability covers all production steps, from raw materials used and machine and operator identification, up to product output and delivery.

- Statistical batch-control during the production process;

- Critical functional dimensions are monitored and documented using a fully automated visual inspection machine;

- Visual inspections, weight control, and leakage testing are continuously checked and documented during production.

The polyethylene (PE), polypropylene (PP) and the polystyrene (PS) used in the manufacture of our products are chosen upon strict quality criteria.

According to the requirements set by our customer, we use:

- Polymers and masterbatches compliant with the current European Pharmacopeia edition;

- Polymers and masterbatches compliant with all direct-food contact EU directives and regulations.

With our flexibility, short reaction times, and capacity to adapt to your market demands, we can readily integrate your supply chain and reply to your current challenges.

Our extensive warehousing facilities allow us to have raw materials as well as finished products, ensuring a seamless supply.

Warehouse temperature conditions are monitored and documented, meeting your highest demands in safety, accuracy and functionality of our products.

John Redin Business Development Director Mobile: + 351 938 282 660 e-mail: john.redin@plasticprogress.com

Progressoplaste, Lda Estrada de Polima, 729 – Abóboda 2785-543 São Domingos de Rana Portugal Tel. + 351 214 454 289 Fax +351 214 452 448 www.plasticprogress.com GPS: 38º43'29"N 9º19'40"W

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