10,000 minimum; TGA approval problematic; supply & demand Potential “shelf-life and packaging issues) double-wrapped and clean room packaging . . . to meet TGA approval . . . makes impractacal fo us for “pharmaceutical” / Clinical use Overseas sterile products NOT approve for Australian use
In Australia be WARY- Importe sterile Vilals DO NOT Conform to TGA Standards and are NOT certified for medical/Pharma use
Due to the Uncertainties Shelf-life issue - Such Hospitals / Pharma Co’s invariably sterilise equipment “IN-HOUSE” . . . Autoclave Equipment etc
ANY compromises . . . NOT Legal or approved / recommended Entirely AT YOUR Risk!
Vials gamma-irradiated CTSC-10V-20T-22D45H-CGS
gamma Irradiated pre-Stopperd before Irradiation Note : Gray Hue is part-evidence of ultra-clean treatment
Supplied : Production Clean But NOT necessarily Organic (VOC) Clean
can be syringe filled 5ml max recommended due to part pressurisation possibilities User Beware
Disclaimer : Fillinig with fluid to 50% momentarily pressuries the vial - on withdrawing needle pressure dissipates Overfilling ( >75% ) can leave residual pressure - on needle re- penetration spurting may occur
USE at Own Risk - Take Precautions These vials are supplied treated washed and “gamma irradiated” NO GUARANTEES or Warranty is offered by Chromalytic and they must be used with asceptic handling procedures where deemed necessary
These gamma-irradiated Vials are supplied for use for R&D laboratory use ONLY by suitably trained technicians, they areNOT Tamper Proof / evident or certified for any particular use. Uses are adviser to use discretion and all due dilgence in applyng them for any given application
Other Sizes ? - ONLY to Custom Order & Large Qtys . . . but ASK!
some “Sterilisation” HINTS . . . To ensure max Sterility - use sterile processes and methodology in ALL handling - Your responsibilty ! . . . strictly to TGA requirements - and may even require YOUR TGA certification for example for final Vial filling - Use a Sterile Syringe Filter 0.22um Pore is regarded as providing a high degree of sterility 0.45um is limited in this respect For “oils” or non polar material use
- PVDF ”SFPVDF025022SG with a 1.0um Glass Fibre pre Filter For water solutions . . .
- Nylon SFNY025022SG
These 0.22um filter can be very slow ie easily blocked
- in which case use 0.45um version then followed by a the 0,.22um for more effective sterilisation 0.45um only achieves a partial sterilisation ( some
The 1um GF prefilter helps remove difficult suspended particulate material preserves/prolongs the life of the main filter
Choice of filter materials is left to users discretion
- PES ( polyethersulfone) a newer media is reported to produce faster and more effective filtration for many water based applications versus Nylon, cellulose acetate etc
Use of full vacuum filtration - flask / funnels vacuum Pump ( motorised ) is recommended for “bulk Solutions” and “initial” cleanup
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