GMP Pilot Plant
GMP Pilot Plant
GMP Pilot Plant
Based in Spain, and with an increasingly international reach, IDIFARMA provides a full range of services that encompasses: drug formulation, development and validation of analytical methods, quality control and batch release in the EU, Pilot-Scale GMPcompliant manufacturing, ICH stability studies, clinical trial logistics management and regulatory support. Our state-of-the-art facility features a purpose-built high containment plant for the manufacturing of GMP-compliant pilot and clinical batches in oral solid dosage forms, for both conventional and high potency drugs. Our pilot plant is equipped with the latest technology and is also used for the optimization of manufacturing processes. IDIFARMA's expertise, capabilities and proven track record make us the perfect partner for the development of your projects.
Fette 1200iC rotary tablet press EU-B and EU-D punch types Fully instrumented Maximum flexibility: from single-tablet pressing with manual filling to actual manufacturing process simulation. IMA Clinipack blister machine Up to 90 blisters/min Maximum flexibility for clinical trials Ability to thermoform and coldform the blisters using all the currently available packaging materials.
Oystar Manesty XL Lab 01 tablet coater Interchangeable drums Batches from 0,5 to 24 litres. Water based and organic solvents Pellet coating capability Advanced control system technology (CFR Part 11 compliant)