|
Applications
Biotechnology is
expected to be the key technology of the 21st century. This is
being encouraged, above all, by the fact that pharmaceutical
authorities are granting more and more approvals to biologically
active substances (API). One of biotechnology's most
important tools is gene technology. It allows humanity to
manipulate the genotype of a living being, to its benefit.
The active substances can be molecules of various types (proteins,
modified sugars, vitamins). The term that has become accepted
for this is API (active pharmaceutical ingredient). They are
manufactured in a cell in increased quantities as a result
of molecular-biological modifications to a gene sequence.
This molecule/mixture of molecules, consisting of cell wall
debris, cytoplasm, protoplasm and cell growth medium can be
separated down to a single substance (target protein; example
of API).
Our equipment is useful when bio-technological process technology
becomes important. The equipment meets GMP standards, is designed
to have little dead spaces, and is built to satisfy all sanitary
requirements. We build fermenters, HTST and sterile steam
equipment, together with their associated controllers and
automation equipment. We subject them to
FAT (factory acceptance test). The equipment is
handed over after acceptance procedures with the customer.
Following transport, erection and connection, the IQ (installation
qualification) and OQ (operational qualification) tests are
carried out. All these activities are documented in detailed
records in accordance with GMP requirements.
|