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Contract Manufacturing
Cold Kits
Radpharm has over 25 years experience in the manufacture of radiopharmaceutical cold kits and associated vials for the Nuclear Medicine Industry.
Our flexible facility allows us to contract manufacture a wide range of Cold Kits and PET reagent vials including:
• FreezedriedproductsusingourGMPlyophiliser• Sterileliquidfilledvialsforcompositekits• Sterilediluentvials• Sterilevialsassembledwithspecialisedcomponentsforproducts whichhavecompatibilityrequirements.• PhaseItoCommercialscaleasepticallyandterminally sterilisedmanufactureforhumanandveterinaryuse
Radpharm distributes cold kits throughout Australia, Asia, South America, Africa and the Middle East.
ProductsInclude
• PYP (Tin Pyrophosphate) - red blood cell labelling• MDP (Medronate) - bone scanning• DTPA (Pentetate) - renal imaging• DMSA (Succimer) - renal imaging• COLLOID (Calcium Phytate Colloid) - liver/spleen scintigraphy• PULMOLITE* (Albumin Aggregated) - lung perfusion imaging• HEPATOLITE* (Disofenin) - hepatobiliary imaging• HDP(Oxydronate) – bone scanning• LEUCOCYTELABELLINGKIT (Stannous Colloid) - imaging infection & inflammation*sponsored kits
NuclearMedicinePlease refer to the GMS website for further details; www.gms-aus.com
SterileVialsSterile vials are a critical component used in the elution and dispensing of radiopharmaceuticals. As a sterile injectable product it is vital that all sterile vials used are manufactured under full GMP conditions. Radpharm can manufacture your sterile vials in both empty and filled forms. All operations are performed under full GMP conditions as governed by the Pharmaceutical Inspection Co-operation Scheme (PIC/s).
Radpharm currently manufactures the following GMP sterile empty vial combinations:
• SEV-Sterileevacuatedvial• SNV-Sterilenitrogenfilledvial• SAV-Sterileairfilledvial
Vials are manufactured in GMP cleanrooms, sterilized using validated cycles with the finished product undergoing 100% inspection and vacuum testing (if evacuated). Vials range in size from 2mL to 100mL; other sizes can be manufactured upon request.
Radpharm also manufactures the following sterile liquid filled vial combinations:
• SSV-Sterilesalinefilledvial• SMV-Sterilemedia(TSB)filledvial• SWV-Sterilewater(WFI)filledvial
To simplify your production process or conduct aseptic process simulation Radpharm’s sterile liquid filled vials are the perfect solution.
AsepticTestKitsUSP<797>Compliance
USP <797> has been revised to ensure consistent compounding standards are set and that patient safety is increased. The guidelines apply to all organisations that prepare compounded sterile preparations and are enforceable by the FDA and other accreditation organisations.
AsepticTestKit(ATK)
The Aseptic Test Kit is used to qualify the aseptic technique of personnel and processes and to ensure that they are capable of producing a sterile product.
The kit uses a standard microbiological growth medium - Trypticase Soy broth (TSB) – as a substitute for the actual drug product to simulate compounding. After use, the TSB will be incubated for a specified number of days and checked for the presence of microbial contamination
Radpharm’s aseptic test kits are tailor made to customer requirements simplifying the validation process and ensuring correct operation.
OtherCapabilitiesAs experts in nuclear medicine, we offer consulting services in the following fields:
• FacilityandDepartmentdesign• RadiopharmaceuticalPreparationareadesignfrom benchtophotlabtofullclassificationandcertification cleanroomfacility• Consultationandsupplyofspecialityequipmentfrom LaminarFlowHoodstoHotCellsfromsyringeshields toautomateddispensersandinjectors• GMPprocessingandValidation• QualityAssuranceandQualityControl• RegulatoryAffairs
RadpharmScientific
PO Box 3334, BMDC Belconnen ACT 2617 Australia Phone: +61 2 6251 6533 Fax: +61 2 6253 3325 www.radpharm.com.au Email: [email protected]
GlobalMedicalSolutions
Central / Head OfficePO Box 115, Arncliffe, NSW 2205
Ph: +61 2 9503 8100Fax: +61 2 9567 [email protected]
RadpharmScientific, a Division of Global Medical Solutions Australia Limited, is situated in Canberra ACT and commenced business in 1986.
Since opening Radpharm has expanded the business to become Australia’s leading nuclear medicine pharmaceutical manufacturing company.
“Tailoredmanufacturing
solutions”
Our Motto“Our mission is to
maintain distinction as
a manufacturer of both
lyophilised and liquid
pharmaceuticals; focused
on manufacturing
high quality product
and ensuring client
satisfaction.”
Our MissionWe are a team – all
employees contribute to the company’s operations
and direction.
As a team we are innovative and not afraid to charter new territory.
As a team we represent our company and believe
in our policies and practice.
OurValues
About
Radpharm ScientificA Division of Global Medical Solutions
NuclearMedicineOur flexible facility and dynamic staff allow us to tailor solutions for all of our client’s needs.
ReadytoUseIndividualSterileComponentsIndividual sterilised components (ISCs) are manufactured by Radpharm and supplied in ‘ready to use’ packaging.
The components are sterile and individually packaged including vials, stoppers and crimps with vial sizes from 2mL to 100mL. Components are packaged unassembled for seamless GMP introduction into aseptic environments.
ISCs are suitable for numerous processes ranging from aseptic filling for small scale clinical trials to large scale supply supplementing vial washer or depyrogenation tunnel operations.
