Key figures
- Maximum volumes of 1 billion tablets/year
- Full containment production
- Production in batch and/or campaign
- Batch sizes till 250 kg
- Maximum 3 shifts per day
- Wet granulation or direct compression process
- Tablet Manufacturing in grade D environment
- Sampling and weighing under isolation and down flow booth in grade D environment
- Secondary packaging (double blistering lines)
- Multi-products facility design
Overview
The Mithra CDMO facility offers a fully equipped state-of-the-art tablet manufacturing department.
The high containment level throughout the process, separate process rooms with PAL / MALs and specific HVAC set-up allows the use of hormonal products.
Batch size can vary from below 100kg up to 250 kg.
The process train includes isolator weighing for API, wet granulation for organic and water based solvents, contained tableting and tablet coating.
Description
The tableting department allows a highly flexible process train without breaking containment. All process steps are in separate zones, each with their own PAL and MAL. The product remains contained using standard IBCs and high-containment valves. To allow a high output, both campaign work and the simultaneous processing of several different products has been taken into account.
Wet granulation is executed using a single pot granulator with dry mill discharge. The granulator can operate with water-based or organic-based solvents. The use of microwaves allows fast and controlled drying. Powder and / or granulate blending and in-batch powder addition are foreseen in a separate room.
A full contained rotary tablet press and separate tablet coater assure full containment until the tablet is ready for packaging.
The cleaning has a high degree of Cleaning In Place (CIP) and Washing Off Line (WOL) to minimize operator exposure and assure a reproducible and highly efficient cleaning process.
With an R&D department in the same building, all expertise is readily available to assist in your process development from small scale to full production scale.
