Sterile or Injectable products

R5 is one of very few companies in Europe that offer contract sterile formulation processes for investigational products. The properties of the API will often indicate the type of sterile product to be developed. Unstable APIs may require aseptic processing. Biotech materials (i.e. proteins and peptides) will almost certainly require freeze drying (lyophylisation). Terminal sterilisation is available for the more durable compounds. At R5 our Grade A, B and C cleanroom complex can handle a wide range of project types including Large Volume Parenterals, and Powder-in-Vial. Our processes are based on a maximum batch size of 10 litres.
 
QP: All clinical batches are released into the European Community by an R5 Qualified Person. 

 

	Autoclaved Products
	Freeze Dried Products .
	Aseptically Prepared Products
	Analytical Chemistry Analytical Chemistry is at the heart of any development project. We create the analytical methods for use by QC to release and assess products and stability indicating methods to enable us to justify the shelf lives of the products we develop. All the dosage forms listed are supported by our in house analytical chemistry teams.