Sanico offers the following services
Production and packaging of non-sterile products:
1. Liquid dosage forms.
2. Semi-solid dosage forms.
3. Unit dose form (tablets, capsules, suppositories, powders, granules).
4. Multi dose form (powders, granules).
See below for a detailed equipment list.
Clinical Trials: production and packaging of clinical trial material.
Characterization Services
Preformulation Services
Formulation Development
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:
Manufacturing
| 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) |
Packaging
| 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; |
Laboratories
- 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
IT-systems
- 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 ...)