Description

The Insupen Needle by Pikdare S.p.A., under the Pic Solution brand, is a specialized pen needle designed for subcutaneous injection. It is intended for use with pen injector devices, making it suitable for administering insulin, peptide hormones, and other medications related to conditions such as diabetes and osteoporosis. This needle is crafted for a wide range of users, from newborns to the elderly, and is applicable in both domestic and professional healthcare settings.

Compatibility

Insupen Needle boasts universal compatibility with all major insulin pens and pen injector devices, verified according to ISO 11608-2 standards. This ensures seamless integration with all major pen brands, providing flexibility and convenience for users.

Design and Features

Available in various lengths (3.5mm to 12mm) and gauges (29G to 34G), the Insupen Needle offers options to meet diverse patient needs. Notably, the 33G / 4mm and 34G / 3.5mm models are among the thinnest on the market, designed to minimize discomfort during injections.

The needle features different wall types, including Regular Wall, Thin Wall, Extra Thin Wall, and Ultra Thin Wall, enhancing medication flow and reducing administration time. Its Super Thin Wall technology, combined with triple sharpening and a silicone anti-friction coating, ensures gentle, low-friction skin entry.

Safety and Sterility

Each needle includes a double-ended cannula with internal threads for secure attachment, an inner needle shield, and sealed medical paper to maintain sterility. A safe remover is included to mitigate the risk of accidental needlestick injuries. The design minimizes coring, fragmentation, and penetration force, although it is marked as MR unsafe.

Materials and Manufacturing

Constructed from medical-grade stainless steel, the Insupen Needle adheres to ISO standards for quality and safety. Other materials include polypropylene for the hub and non-toxic polyethylene for the needle shield. Medical-grade silicone is used as a lubricant, and non-toxic UV glue secures the hub-to-needle bond.

Sterilization

Sterilization is achieved using ethylene oxide, with processes validated per ISO standards, ensuring a sterility assurance level of 10⁻⁶. The needle is biocompatible, exhibiting no adverse effects such as cytotoxicity or sensitization.

Regulatory Compliance

The Insupen Needle meets or exceeds several international standards, including ISO 11608-2 and ISO 7864. It is CE marked and classified as a Class II medical device under 21 CFR 880.5570, suitable for over-the-counter use.

Packaging and Shelf Life

Packaging includes a blister with a high-density polyethylene container and a medical-grade paper seal. Each sales box contains 100 needles, with 12 boxes per transport carton. The product has a shelf life of five years, contingent on packaging integrity and proper storage conditions.

Manufacturing Excellence

Designed and manufactured in Italy, the Insupen Needle has seen over 4.6 billion units produced since 2000. Its design leverages substantial equivalence to predicate devices, negating the need for clinical data while demonstrating no adverse biocompatibility effects in testing.