GIPHARMA Radiopharmaceutical Freeze-Dried Products and Sterile Components

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.

Liquid fill and lyophilization, QC analytical testing, radiochemical analysis and aseptic manufacturing processes

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:

• Liquid fill and lyophilization
• Complete aseptic manufacturing processes for both clinical trials materials and commercial batches
• Full support services such as microbiological and QC analytical testing
• Stability monitoring programs and testing services
• Labelling and packaging
• Batch release
• Wide range of chemical and radiochemical analysis

Injectable products requiring aseptical manufacturing process or terminal sterilization

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.

Sterile freeze-dried vials and radiopharmaceutical cold kits

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.

Terminally sterilized injectable solutions

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.

Sterile components for PET isotope manufacturing centres

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:

• Sterile vacuum vials
• Sterile saline elution vials
• Sterile disposable components
• Sterilization services for reusable components
• Radionuclidic measurements
• Microbiological tests on radioactive products
• Environmental microbiological testing programs
• Design and support of customized validation programs

Aseptic processes and filling and lyophilisation operations

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.

Pharmaceutical injectable and lyophilized preparations

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.

Radiochemistry laboratory for quality control tests

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.

Chemical quality control tests

The chemistry laboratory performs all required chemical quality control tests both for materials acceptance and for final product release. Some examples of instruments:

• Volumetric Karl Fischer instrument – Metrohm
• FT-IR and UV spectrophotometers
• Hyac-Royco particle sizers
• GC with FID detector and HPLC with diode array detector and flow count FC3200 radiodetector Bioscan
• Polarograph with voltammetric quantitative analysis of metals
• ICP optical emission spectroscopy
• TOC analyzer

Sterility and pirogenicity testing, bioburden tests and preparation of broths for media fill tests

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).