Production and packaging of non-sterile products:
- Liquid dosage forms.
- Semi-solid dosage forms.
- Unit dose form (tablets, capsules, suppositories, powders, granules).
- Multi dose form (powders, granules).
See below for a detailed equipment list.
production and packaging of clinical trial material.
Methods Development and Validation
Analytical methods can be developed and validated by ICH or other parameters for drug substance and finished product.
Stability Studies (ICH), Storage and Testing
Our stability operations have extensive storage capacity for all ICH conditions as well as custom storage conditions.
All our chambers are continuously monitored by a computerized central monitoring system and are on full generator back up.
Quality Control/Compendial Analysis
We perform API and excipient testing of all compendial methods for global release purposes (USP, PhEur,… ).
We also have extensive experience for finished product analysis, in-process support and manufacturing validations
Summary of available equipment
- 8 fully automated HPLC systems (Detectors UV/VIS & RI / DAD) with CDS software
- 2 GC systems (FID & TCD) + head space sampler
- Infrared Absorption Spectrophotometer
- UV/VIS Spectrophotometer
- Dissolution Test: basket and paddle apparatus
- Physical and physicochemical testing, identification tests, limit tests, assay determination and pharmaceutical technical procedures
- Microbiological test: total viable count, test for specified micro-organisms, preservative efficacy testing
- Microbiological monitoring of purified water
- Environmental Monitoring
- Stability rooms for ICH stability testing:
25°C – 60%RH
30°C – 65%RH
30°C – 75%RH
40°C – 75%RH
- Room for storage at 5°C
- Manufacturing Execution System (MES)
- Warehouse Management System (WMS)
- Material Requirements Planning System (SAP R/3)
- Quality Management System (CATSWEB)
- Central Monitoring System (CMS)
- Chromatography Data System (CDS)
- Training Management System (SQTS / SQAS)
- Laboratory Information Management System (LIMS)
- Stand alone applications for controlling and managing specific manufacturing equipment (Fette, Kraemer, Vector, Accela Cota, Glatt …)
|Mixing, granulating equipment||2 x Gral 300 ; 1x Gral 600 ; 3 x conical|
|Drying equipment: fluid bed, tray dryer||Fluid bed Glatt 1500 (capacity 650 kg), Vector (capacity 90 kg) both fluid beds equipped for fluid bed granulation (WSG) or in combination with high shear granulator; Lytzen tray dryer (capacity 180 kg)|
|Dry and wet mills||KEK; Quadro; Fitzmill; Frewitt|
|Final blending||2 x Tumbler for IBC’s 1500 l or drums 100 or 200l|
|Tablet presses||3 x Fette 2090; 2 x Fette 1200; 1 x Fette 2100; 2 x Fette 3100; 1x Kilian RX67….. (tooling EU B, BB, BBB, D)|
|Capsule-filling machine for hard gelatin-capsules||Bosch 1x GKF 2500; 1x GKF 1500; 1x GKF 1200…..|
|Film- and sugar-coating equipment||1x Accela Cota 350 (non ex); 1x Accela Cota 150 (ex proof); 1x Accela Cota 150 (non ex)|
|Semisolid preparation vessels||Ahlborn 400 l for crèmes, ointments suppositories; Unimix 15 l pilot plant|
|Liquid vessels||Packo 5000 l (non ex); 2000 l (non ex); 1000 l (ex proof)|
|Blister lines: blistering, packing and wrapping machines||5x Uhlmann 1030 MTI blister machines in combination with C2155 cartonner, 1x Klöckner Hänsel CP10 + C2155, 1x Klöckner Hänsel CP8 + C130. All lines have online (unitdose) printing and are able to run all thermoforming and cold forming foils with (cross) perforation; wrappers Skinetta, Pester; checkweighers OCS, Bosch.|
|Liquid filling lines: filling, labeling, packing||Gröninger DFK 6001 / MCS for bottles 5 ml up to 300 ml (up to 7200 bottles/hr), Farmomac F57 for bottles 5 ml up to 500 ml (up to 4000 bottles/hr)|
|Tablet/capsule counting equipment||Gordic tube filler (dia 16, 20, 25 mm), Cremer container filler|
|Powder filling equipment (bottles, containers)||Optima screw dosing powder filler (2 gr up to …)|
|Sachet filling equipment||Klöckner Hänsel LA160 for powders (0.5 till 5 gr), tablets, liquids and semi solids (1.0 up to 100.0 ml) able to run paper and multiplex foils.|
|Labeling equipment syringes and vials||Rota, Baush & Ströbel, Neri, Herma|
|Semisolid filling line||Kalix Dupuis KX80 2ml up to 100 ml metal tubes (up to 4000 tubes/hr), Crespi suppository filler (up to 10000 suppo/hr) in PVC (PE) preformed (and printed) moulds;|