Our laboratories offer you cost effective cGMP manufacturing of smaller quantities (gram scale) API's. The kilo lab enables us to conveniently bridge the gap between lab and pilot scale and our chemical production plant is designed for multi-purpose use in small to full scale, ranging from kilo to multi-tons.
For early clinical demands
Our laboratories offer you cost effective cGMP synthesis of smaller quantities (gram scale) API’s. High flexibility and technical standards allow us to handle your project efficiently. We perform multi-step synthesis and are experts in handling high potent compounds. cGMP standards are applicable also at this scale.
For your clinical API demand in kilo scale
Our kilo lab allows us to conveniently bridge the gap between lab and pilot scale. It is perfect for the synthesis of quantities between 500 gram and 3 kilo and it will provide you with substances for toxicology studies and early clinical trials most efficiently.
Presently, the following equipment is in place:
Our process R&D chemists, who take your process all the way from lab to full scale, operate the kilo lab. A containment operating system allows handling of high potent substances.
Multi kilogram GMP Synthesis
Our pilot plant is a multi-purpose plant and runs according to cGMP. We have 10 different reactors with volumes ranging from 50 liters to 1000 liters giving us the capability to produce your preclinical development and clinical trial material.
We can go up to a pressure of 10 bars and down to a temperature of – 100 C. We have filters and a centrifuge for isolation.
For dry materials handling we have a separate isolation room with airlocks. Our vacuum drying cabinet allows us to dry materials from 1 to 50 kg (Air Class 100,000 qualified – EU GMP, class D).
Our R&D chemists and the dedicated pilot plant engineers work closely together to allow for a smooth transfer from the lab to the pilot plant. The pilot plant is very well correlated to our full scale production equipment, so it is ideal for a seamless process scale-up.
For your commercial demands
Our chemical production plant is designed for multi-purpose use in small to full scale, ranging from kilo to multi-tons. By separation into four different production units, cross contamination is avoided.
Illustration of the plant with four separated production units:
We have 12 different reactors with volumes ranging from 900 liters to 6000 liters. A typical volume is 2500 liters giving a typical batch size around 200 kg. Isolation is mostly made by centrifugation and each unit has its own centrifuge.
Drying, sieving or milling and packaging take place in separate drying chambers complete with an airlock system preventing contamination from the outside.
By rigorous procedures and extensive training of our operators, we can handle substances with Occupational Exposure Limits (OELs) down to 10 µg/m3 in our regular production.
The plant has its own proactive maintenance crew responsible for calibration of instrumentation as well as all maintenance of equipment and buildings.
Handled with care
We have designed this unit especially for reactions with highly potent compounds or for producing high potency API’s.
We can handle substances with Occupational Exposure Limits (OELs) down to 30 ng/m3. The principle is to keep the substances contained within the equipment at all times.
Our operators can use standard protective gear when operating the unit. The unit is also simple to clean. It is furnished with airlocks for operators and materials. The air is HEPA-filtered.
Charging and discharging of solids are the critical operations from a safety point of view and this is made through a specially designed system made by Zanchetta. The Zanchetta-system can be connected to both the Rosenmund reactor/filter/drier and to the two glass lined reactors. Typical batch sizes range from 5 to 15 kilo of dry API.
The staff operating in the Contained Unit are specially trained and have long experience in handling highly potent materials.
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