Micronclean has announced a re-branding of its pharmacy pack range, as “microndevices”.
Originally known as ‘Sterile Packs’, the range comprises syringes, needles, vented and non-vented access devices plus a range of sterile accessories including pens, labels and waste bags.
Since 2018, the MicronDevices products have been packed in Micronclean’s own purpose-built ISO Class 6, EU GMP Grade C cleanroom in Skegness, Lincolnshire. Micronclean’s unique BRC (Batch, Record and Control) software provides traceability from the finished batch back to each critical sub-component lot and additionally compiles an electronic batch record, eliminating the need for paper records. Each product is UDI (Unique Device Identification) and NHS Scan4Safety compliant.
The MicronDevices process, from the sourcing of components through to delivery of orders is certified to ISO 13485 – the quality management system for medical devices. Additionally, those packs designated as medical devices, are CE marked under the EU regulation 2017/745 and CA marked under the UK regulation 2002.
Our standard range of packs plus the bespoke service and pack and irradiation facility, together with Micronclean’s large consumables range, means that we can provide critical sterile products to meet our customers’ every need
In addition to the standard MicronDevices range, Micronclean creates bespoke packs to suit the individual needs of customers and their compounding sessions. Working closely with the customer, Micronclean will take a requirement from concept through to delivery, managing the entire process using in-house expertise in such areas as packaging, labelling, sterilisation and regulatory compliance.
Micronclean knows that many customers have a requirement to have various materials irradiated to enable them to be used in a clean area.
The ‘Pack and Irradiate’ service was developed to meet this need. Micronclean will work with the customer to determine irradiation compatibility of materials and the best packaging options. Materials processed under this service have included labels, tubing, bottles, pipettes and many more.
Micronclean’s Medical Device Technical Specialist Philip Borrington said: “We are delighted to launch this rebranding of our pharmacy range as MicronDevices. Our standard range of packs plus the bespoke service and pack and irradiation facility, together with Micronclean’s large consumables range, means that we can provide critical sterile products to meet our customers’ every need. Our transition to the new EU Medical Device Regulation and adoption of NHS Scan4Safety requirements demonstrates our commitment to meeting both regulatory and customer requirements”.
