Radiopharmaceutical Freeze-Dried Products and Sterile Components
Strada Crescentio, 13040 Saluggia (Vc),Other, Italy
GIPHARMA manufactures radiopharmaceutical freeze-dried products using custom manufacturing and analytical services.
GIPHARMA has supply and service agreements with the main imaging players in Europe and manufactures a variety of radiopharmaceutical freeze-dried products for them. GIPHARMA can also provide support services to PET radiopharmaceuticals manufacturing units.
GIPHARMA’s mission is to provide custom pharmaceutical product manufacturing and support services, coupling flexibility and customer focus with compliance to the highest quality standards. GIPHARMA can offer a wide range of custom manufacturing and analytical services under cGMP requirements, including:
GIPHARMA can manufacture injectable products requiring either completely aseptical manufacturing process or terminal sterilization. GIPHARMA can release batches requiring chemical, microbiological, radiochemical, biodistribution and acute toxicity testing.
Radiopharmaceutical cold kits are freeze-dried injectable solids to be reconstituted with sterile technetium (99m Tc) solution. The labelled compounds, once injected, allow the execution of specific nuclear medicine diagnostic procedures. In addition, Gipharma produces (as a third-party manufacturer) sterile injectable freeze-dried products for several pharmaceutical companies.
Lyophilization batch size can reach 14,000 vials (15ml capacity). Current production volumes of freeze-dried products are in the range of 900,000 vials per year. Plant capacity can reach 2 million vials per year.
GIPHARMA currently manufactures terminally sterilized injectable solutions in small vial format (up to 20ml size) with a capacity of up to 30,000 vials per day.
GIPHARMA can support the quickly growing number of PET isotope manufacturing centres in their daily activities with a complete range of fully GMP-compliant services and products, such as:
The controlled area occupies a total of 205m². Inside there are two B/A class sterile rooms totalling 70m². The first is dedicated to completely aseptic processes and the other to the filling and lyophilization operations. The controlled area also contains three C class preparation rooms totalling 70m² dedicated to the preparation of the materials needed in the sterile rooms.
GIPHARMA’s clean rooms are fitted with standard equipment for pharmaceutical injectable and lyophilized preparations, among which are a 6.5m² shelves area with a steam sterilizable Telstar freeze dryer; a 3m² shelves area with an Edwards freeze dryer; a 5,000 vials/hr Corima filling line under laminar flow; a purified water production and distribution system; and a Fedegari autoclaves and depyrogenating oven.
GIPHARMA’s radiochemistry laboratory is dedicated to quality control tests requiring radioactive isotopes, such as labelling efficiency tests, radionuclidic purity tests, sterility tests of radioactive injectable products and biodistribution tests. This laboratory also performs tests aimed at the environmental monitoring of radioactive procedures.
The chemistry laboratory performs all required chemical quality control tests both for materials acceptance and for final product release. Some examples of instruments:
The microbiology laboratory is dedicated to the sterility and pirogenicity testing for final product release, to the bioburden tests on starting materials, air and surfaces during manufacturing processes, and to the preparation of broths for media fill tests.
It consists of a class B suite for sterility testing; an isolator in a class C environment for sterility testing of radioactive products; a dedicated kitchen for media preparation; and different temperature incubators dedicated to stability testing (according to ICH guidelines).
Torrent Pharmaceuticals and Novo Nordisk India opened a new greenfield insulin and parenteral facility at the former’s parenteral facility in Indrad, Gujarat, India, in December 2017.
Strada Crescentio
13040 Saluggia (Vc)
Other
Italy