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Sterile Vials
Discontinued
2013

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!

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 are NOT Tamper Proof / evident or certified for any particular use.
Uses are adviseD 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 ) iscertainly  recommended
for “bulk Solutions” and “initial” cleanup

Filtration, Vac Pmps

OPEN Invitation
to Sterilsation
. . . OEMs

we are open for business ! - offers of products
PROOF of TGA approval;  small Quantities, fast turn-around - proper packaging essential ! . . . certification date-stamped and Guaranteed !
IMPORTED “STERILE” Products are NOT viable NOR acceptable to us !

Import at YOUR Own Risk need “sterile”reprocess in AUST
> re TGA legalities & repackaging < dble wrap !

Be-A-WARE !

Certain APPS require
Clean-Room” facilities !

Common Sense & YOUR
Due Diligence IS Required !

or WORSE !

IF U r Not 1 OF THE “boys” U RISK BEING “CANCELLED”

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“Without Prejudice“ !

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