Sirton Pharmaceuticals conducts the development and validation of manufacturing processes satisfying all the rules required by the European Regulatory Authorities.
The main steps and responsibilities are:
The Manufacturing Department sets a detailed master batch record starting from the draft manufacturing process issued by the Technology Transfer Team.
The Validation Team makes a risk assessment on the master batch record and defines the process steps with highest impact/risk for product quality and the relevant IPC (in-process control) to conduct. A validation protocol is issued.
The Validation Team checks equipment validation for all the equipment involved in the manufacturing and analytical process.
The Validation Team checks the impact on the cleaning validation and, if necessary, conducts cleaning validation activities with the support of the laboratories.
Quality control laboratories perform IPC, release and stability analyses
Sirton Pharmaceuticals can offer customers a choice of disposable technology solutions (a process diagram is available in the download area).
The development process is very similar to the development of standard manufacturing technology yet has several advantages.
Preparing and receiving solutions in disposable bags makes it possible to obtain:
- a drastic reduction in the risk of cross-contamination
- reduced costs for cleaning validations
- high volume scaling-up (0,5 - 2,000 litres)
- simple processes easy transferable
Compatibility and Validation studies can be performed by the bags supplier at the same time as filter validation with no additional times. All parts in contact with the product can be either single use or dedicated.
Sirton Pharmaceuticals has three laboratories: Chemical, Biological and Microbiological.
Each laboratory is able to apply EUPH/USP/dossier analytical methods.
Their main equipment and technical capabilities are listed in the table beside.
|High performance liquid chromatography||ACL (coagulation factor)||Isolator|
|Gas chromatography||LAL chromogenic testing||Biohazard cabinet|
|Infrared spectrometer||SDS-immunoplotting||Microbiological identification|
|Ultraviolet spectrum analyser||Laminar flows|
|Karl Fisher titration||Incubators|
|Total organic carbon analyser|
|Chemical assays||Biological assays||Microbiological assays|
|HPLC impurities||Total bacterial endotoxins||Bacterial count|
|HPLC identifications||SDS-page||Sterility test|
|Preservative effectiveness test|
Liquid (vials, ampoules, pre-filled syringes)
Freeze dried (vials)