7/29/2019 Gmp Pilot Plant

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7/29/2019 Gmp Pilot Plant

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GMP Clinical and Pilotbatch manufacturing

IDIFARMAs cGMP-compliant pilot plant is equipped

for the manufacturing ofsolid oral dosage forms ofboth conventional and high potency drugs (cytostatic,

cytotoxic, hormonal, hormone inhibitors). Our

authorization also includes the manufacturing of placebo

formulas necessary for many clinical trials.

Highlights:

Fully GMP certified facilities.

Tablet manufacturing capacity: Clinical and Pilot-ScaleBatches (complying with EMA Scientific Guidelines).

Capsule manufacturing capacity: Clinical Batches.

Highest quality equipment from top vendors (Httlin,

Fette, Manesty, IMA) that ensures a smooth tech

transfer to industrial manufacturers.

Equipment with advanced control systems

technologies (CFR Part 11 compliant).

Ability to manufacture with organic solvents.

High containment (if necessary): 100% air renewal,

personal protective equipment, paperless

manufacturing guides, remote data acquisition system.

Maximum flexibility to meet clinical trials

requirements.

Future investment plan for two new Pilot Plants:

sterile products and conventional products.

The plant can also be used for optimization ofproduction processes, pursuing goals such as reducing

costs, eliminating waste, improving lead times and

taking full advantage of production equipment features.

Manufacturing processoptimization

IMA Clinipack blister machine

Up to 90 blisters/min

Maximum flexibility for clinical trials

Ability to thermoform and cold-form the blisters using all thecurrently available packaging

materials.

Oystar Httlin Pilotmix75T single-pot high shearmixer

Single pot, top drivetechnology

Capacity up to 75 litres

Organic solvents capability

Advanced control system

technology (CFR Part 11compliant)

Cleaning-In-Place system

Up to 200 litres bins

Fette 1200iC rotary tabletpress

EU-B and EU-D punch types

Fully instrumented

Maximum flexibility: from

single-tablet pressing withmanual filling to actualmanufacturing processsimulation.

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)