Micronclean are registered to BS EN ISO 13485:2016 which covers every aspect of sourcing, manufacturing, sterilisation and distribution of the sterile pack range. A virtual reality walk-through of the sterile packs facility allows you to navigate the premises and discover more at each information hotspot.
1. Good Inwards
A basic quality check is performed on the boxes as they arrive
Goods that pass the inwards inspection are booked into the Batch Record Control (BRC) system
The BRC system generates a 2D barcode label to ensure full traceability when goods are moved into the warehouse
2. Production Order Picking
A picking list is generated from the product bill of materials (BOM)
Printing a 2D transfer barcode allows traceability of all components transferred into the cleanroom
3. Cleanroom Inwards Transfer
External cardboard packaging is removed from all the products
Outer bag is removed and goods are placed in the transfer hatch
Single bagged product is transferred into the cleanroom
4. 100% Visual Inspection
A tip protector is fixed on the approved syringes
Approved syringes go into a grey bin
Rejected syringes go into a red bin
5. Label, Seal and Pack
The primary pouch is filled
Primary pouch is sealed
Primary pouch is placed inside a secondary pouch, which is then sealed
Optional triple packing is then applied if requested
6. Transfer of Final Product
Transfer trolley is placed in dedicated transfer area, but does not cross the yellow line marked on the floor
From outside the cleanroom, the first pouch is scanned for traceability and transferred into shipping boxes
Boxes are then placed onto a pallet
7. Shipping Boxes and Labels Are Prepared