Macsa ID, a leader in marking, coding and traceability solutions, together with Adents, experts in serialisation, are proud to present SERIAL FARMA, the most comprehensive global solution to comply with the new mandatory regulation on pharmaceutical serialisation.
The Falsified Medicines Directive (Directive 2011/62/EU) establishes solutions to combat counterfeit medicines. It is a key priority in the Medical and Pharmaceutical Sector as all pharmaceutical laboratories with prescription medicines must comply with the EU-FMD before the deadline of 9th February 2019.
On the 5th October we attended the ‘Are you ready for serialisation?’ conference organised by AECOC (in Madrid), where we participated in the roundtable to discuss the new regulations, inform manufacturers of the effect they will have and offer our different solutions. We were also present at the same event held in Barcelona on 18th October.
This new directive introduces measures to reinforce the security of the supply chain of prescription medicines, with the obligation to include a serial number on the outer packaging of each product, in the form of a unique, individual and readable number, using a 2Ddata Matrix barcode, added to anti-tampering devices which will allow the verification of medicines before being dispensed to patients.
This directive concerns manufacturers of pharmaceuticals, importers, third-party packers and wholesale distributors of medicines within the EU, as well as manufacturers of active ingredients (API’s) which are supplied to EU companies.
The regulations affect all levels of packaging:
Although encoding blisters is not obligatory by law, it is still advisable to identify them individually. This option is especially useful for hospital medicine control, in which single doses are administered to patients. The blisters are identified with the batch number and the expiry date.
The ideal equipment for encoding blisters is laser coders and large character high resolution ink jet technology. The marking is done on the aluminium film before it is applied on the blister and both technologies allow the marking process to take place at the high production rates required by the manufacturing lines.
Each individual case must be marked with codes that ensure a global unique product classification made of a serial number optionally combined with a “tamper-evident” label that ensures that the case has not been handled in any way. This serialisation ensures transparency of the origin of the product to the retail point of sale.
Macsa ID offers laser equipment or small character high resolution ink jet markers (TIJ) for the case coding. For the “Tamper Evident” sealing system Macsa ID has the MLA labelling equipment. All these technologies enable the marking process to take place at the high production rates required by the pharmaceutical manufacturing lines that can reach up to 400 products per minute.
This first level of aggregation contains pre-serialised cases. The coding of this level allows the consolidation of the serial numbers of the cases it contains into a new independent serial number for the whole set.
Macsa ID offers equipment for printing and labelling idBlocks (Print & Apply) and large character, high resolution printers (DoD).
This last aggregation level contains several levels of pre-serialised packaging. Labelling pallets allows the serial numbers of the products comprising the pallet to be consolidated into a single SSCC pallet registration.
Macsa ID offers Print&Apply equipment (idBlocks Pallet) for printing and labelling pallets.