Nicomac’s-Euronovis’ 800 square meter (8,000 sq ft) facility certified by Italian authorities ATS Milano, N°18 dd 20.04.2016 “production of food supplements, in particular A.D.A.P. (Foods for particular nutritional uses) and A.F.M.S. (foods for special medical purposes)” within 2019 GMP certified for food supplements.
All our operators have been instructed to work according to quality procedures which include: preparation, production, washing, cleaning, sanitizing.
All products are checked, before and after processing, as follows: visual inspections, tests of hardness, friability, weight, moisture of tablets or pellets. A disintegration test will be performed in the case of enteric coated tablets.
Regarding “coating” process, the following Euronovis equipment (fully automatic and with PC+PLC control) are available:
- FBD FLUID BED DRYER 8: 16 litres useful capacity – 8 litres min. capacity
- LAB 50 COATER: 50 litres useful capacity – 10 litres min. capacity
- N°4 NCS 350 COATER: 350 litres useful capacity – 70 litres min. capacity
The Euronovis capacity is approximately 260 million tablets a year with one shift. We coated more than 300 different types of tablets.
Inside our laboratory, we follow procedures for machine and environment cleaning. These procedures state cleaning materials and its frequency. Moreover, we record and store the relative documentation. Periodically, we carry out swabs on enviorments and machines and then we send these swabs to an authorized laboratory which checks bacterial load and the presence of allergens. Moreover, procedure to keep the enviorments free from weeds, rodents, birds and insects are in force.
Personnel is equipped with dedicated suits and it is trained according to programs which are registerd. Personnel has procedures and operational instructions (behaviour, maintenance, cleaning, working) at its disposal. We purchase raw materials from qualified suppliers. Raw materials are identified and stocked in suitable warehouse together with their analysis certificates, technical data sheets and msds.
Periodically a sample of each raw material is analyzed by an authorized laboratory in order to verify cleanliness. Water used is periodically analyzed to check its potability.
Upon request we can use raw materials in compliance with Kosher and Halal norms.
Customer’s product is stocked in suitable warehouse, waiting for coating. Before coating, physical analysis are carried out on samples which are classified and stored. Our personnel record all incoming materials as follows: description, code, incoming date, batch number, quantity, expiry date. For each product, there are solution preparation recipes (solution recipe) and instructions for film coating process (film coating recipe). For each production batch, its documentation is filled up and stored (working sheet, analysis certificate, batch release), thus granting batch and film component traceability.
- Research & development
- Formulation optimization and scale ups according to FDA guidelines and small-scale production