Plastiape Medical Devices and Pharma Packaging Solutions
Plastiape has ISO: 7 and ISO: 8 cleanrooms available with moulding machines and assembly lines for manufacturing high-quality medical devices for respiratory applications, ophthalmic packaging, drug containers, bottles and tubes with closures and accessories.
Manufacturing of products for medical devices
With strong expertise in moulding plastic compounds, Plastiape can manufacture products in a wide range of polymers, including ABS, COP, PE, PP, PET and POM.
The company uses technical professionals and regulatory experts to ensure development efficiency and capability to satisfy demanding client expectations on formalised design control.
Plastiape specialises in compliance-related matters, including preparing and filing FDA drug master files (DMF), as well as CE Marking of medical devices.
Dry powder inhaler for therapeutic treatment of respiratory diseases
The RS01 Dry Powder Inhaler was the result of a large and intensive re-design of a pre-existing model manufactured by the company since the late 1970s.
A key improvement of the RS01 compared with pre-existing monodose devices is the innovative design of its piercing unit, which required studying new manufacturing techniques and a different assembly sequence.
Investing in pilot tooling and a new assembly line was crucial in achieving optimal component design and assembling solutions for the large-scale industrialisation stage.
Over more than a decade, millions of RS01 devices have been successfully delivered and used for therapeutic treatment of respiratory diseases worldwide.
RS01 has a robust design, resulting in top performance and reliability, allowing the device to become part of the current medical device market.
Low and high resistance inhalers
RS01 is marketed in combination with different drug products, based on milled or spray-dried powders, filled into hard-gelatine or hydroxypropyl methyl-cellulose (HPMC) capsules.
The device was designed as a low-resistance inhaler, but modified versions with higher resistance are also available depending on different client requirements, further expanding its scope of application.
Pharmaceutical research companies studying radical therapeutical innovations aim to improve quality of life, or search for treatments of diseases than an efficient remedy is not yet available for.
Many research companies cannot afford the high costs and long lead-times necessary to design and industrialise a new DPI.
Reliable and affordable dry-powder inhalers help research laboratories bring their innovations to clinical studies.
Multi-component medical devices and integrated packaging solutions
The company supplies products to clients in more than 40 countries worldwide.
Plastiape offers standard and customised multi-component medical devices, integrated packaging solutions such as bottles and accessories, as well single items including droppers, measuring cups, tamper-evident and child-proof closures.