Biotechnology is the use of biological processes, organisms, or systems to manufacture products intended to improve quality of human life. Recent biotechnology is associated with landmark breakthrough in new medical therapies to treat diabetes, hepatitis B, cancers, hemophilia etc. One of the important biotech products is rDNA human insulin, which was marketed first in 1978. In modern medical treatment these drugs have gained huge growth worldwide as they play pivotal role in the treatment of diseases.
The manufacturing of these drugs is very critical. Understanding the importance of the critical manufacturing challenges Aristopharma has set up a high standard facility including class 100 clean room, HVAC system etc. for crystallization, filling, sealing of its insulin products. Moreover, to maintain storage temperature it maintains complete cold chain throughout the distribution network with specialized vehicles, refrigerators, cool gel bag etc.
Aristopharma manufactures insulin of 5 categories, i.e. Insulet R, Insulet N, Insulet 50/50, Insulet 30/70 and Insulet GN. It also manufactures erythropoietin in 4 strengths, i.e. Nipotin 2000 IU/0.2 ml, 3000 IU/0.75 ml, 4000 IU/0.5 ml and 5000 IU/0.5 ml. In addition to Insulin some more products like analogue insulin, filgrastim, peginterferon etc. are in pipeline of Aristopharma biotech portfolio.
Insulin Crystallization, Filling & Sealing
Each & every operation in manufacturing insulin is done as per cGMP guidelines. Highly purified insulin crystals are produced with this ultramodern machine maintaining ambient temperature (18 - 25° C) for 24 hours.
Filling & Stoppering
Insulin is filled by fully automatic high-efficient 12-nozzled machine without any human touch. Stoppering is done automatically.
Nozzle no. 1 to 4: N2
gas is purged to make the vial oxygen free >
Nozzle no. 5 to 8: Insulin is filled >
Nozzle no. 9 to 12: N2
gas is purged again for extra protection from oxidation
The filled Insulin vials are then sealed with with special grade rubber stopper & flip off seal by the sealing machine > Labelling & cartoning > Finished products
Cold Chain for Insulin Distribution
Considering the importance of storage temperature (2° C to 8° C) of Insulin the company strictly maintains cold chain for its Insulin from the factory to chemists end. Without depending on others Aristopharma has set up its own cold chain throughout the entire distribution network for its biotech products.
Special storage vans, cool gel bags, cool boxes, special refrigerators, skilled manpower etc. are the key components of its cold chain distribution network.