Laboratory : controls, development, stability and clinical batches
Sirton Pharmaceuticals offers comprehensive support throughout the product lifecycle , from development to clinical batch production . With dedicated departments for Quality Control, Production Development, Stability Studies, and clinical batch management, we guarantee technical expertise , regulatory compliance , and maximum operational flexibility .
Quality Control Department
Sirton's Quality Control (QC) department is essential to ensuring that pharmaceutical products meet the required quality standards .
The QC department includes all measures taken to ensure that raw materials , semi-finished products and finished products conform to the established specifications for identity, strength, purity and other characteristics.
Productive Development
Sirton Pharmaceuticals has an internal Product Development department dedicated to the development and/or optimization of pharmaceutical products and medical devices .
The activity includes the optimization of freeze-drying cycles , the development of chemical , biological and microbiological analytical methods, as well as the procurement of materials necessary for production (excipients, APIs, etc.).
Pilot freeze-dryer
A pilot freeze-dryer is available to develop and refine new freeze-drying cycles, supporting product stability and efficacy.
Chemical and microbiological methods
The department develops accurate analytical methods , using appropriate techniques and instrumentation , in compliance with international standards (ICH) , to guarantee safe, effective products that comply with current regulations.
Stability studies
The stability department is dedicated to evaluating the durability and quality of products over time , verifying that they maintain their effectiveness and safety throughout their entire shelf life.
All studies are accompanied by relevant documentation and are conducted in climate chambers according to ICH conditions, available at: 5°C, 25°C / 60% RH, 30°C / 65% RH and 40°C / 75% RH.
Clinical batches
Sirton is authorized to manufacture batches for clinical studies , including therapeutic packaging and labeling based on randomization codes provided by the CRO .
We guarantee extreme flexibility in production batch sizes and the delivery of therapeutic kits directly to Clinical Centers .