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TOC Cleaning Validation Kit Y-3342

China Factory Directly Sell Medical Surgical Cleaning Validation Swabs Free Sample Hygiene Swab

Huachenyang TOC Cleaning Validation Kits were designed tosimplify sampling as part of a cleaning validation protocol. The swabs and vials are further cleaned using a proprietary process to make these kits excellent for use in Total Organic Carbon (TOC) analysis. Lot coded for traceability and quality control.

Použití:

1.Surface sampling in: TOC analysis as part of a cleaning validation protocol
or As part of other cleaning validation protocols
2.Non-organic liquids sampling for contamination source investigation.

Bulk Cleaning Validation Kit dimension:

TOC Clean validation kit:

jméno výrobku

TOC Cleaning Validation Kit---CY-3342

Patent č. V Číně

4970329,4968923,4969907,4262124,4970026,4262124,4969319

Osvědčení

FDA, CE, EU, volné prodeje, vývozní licence na základě (GMP)

Bulk Cleaning Validation Kit content

 

72 pcs 40 mL clear vials bonded septa caps, certified <10 µg/L TOC

144 pcs CY-715A Low TOC iCleanhcy® Swab with Long Handle, certified <50 µg/L TOC

72 blank vial labels

Aplikace

1.Surface sampling in: TOC analysis as part of a cleaning validation protocol

or As part of other cleaning validation protocols

2.Non-organic liquids sampling for contamination source investigation.

neplodnost

Sterilní

skladování

Teplota v místnosti (15-30)

Balíček

18 kits/Case

Skladovatelnost

1 rok

Kapacita

480,000 kits/15 days

OEM / ODM

Přizpůsobení designu, barvy, loga, balení, tvaru tampónu a bodu zlomu

Dodací lhůta

12-18 dnů od uložení

MOQ

2 Cases

Platba

L / C, T / T, Money Gram, Escow, Paypal, Western Union, DDP, DAP

lodní

Po moři, vzduchem, Express DHL, Fedex, UPS nebo TNT

TOC Clean validation Kit:
1. Organized, convenient and secure method for transporting swabs and vials from storage area to sampling sites to laboratory with minimal chance of contamination.
2.Three size options available.
TOC Clean validation Vials:
1. Certified Low TOC level (<10 µg/L, <10 ppb) ensures consistency in vial background contribution.
2. Pre-washed borosilicate glass vials have a one-piece cap an septa design for easy sampling and analysis.
3. Septum thickness – 1.34 mm (0.053")
4.Polyethylene overcap protects septum surface from contamination until time of analysis.
5.Sloped shoulder design minimizes headspace for reduced background TOC level.
6.Endorsed for use by TOC instrumentation manufacturers
TOC Clean validation Swab:
1.Certified Low TOC level (<50 µg/L, <50 ppb) ensures consistency in swab background contribution.
2. Double layered, double knit polyester head entraps contaminants in knit structure during sampling. This allows maximum contaminant collection and release into the diluent to provide for excellent recovery rates.
3. Notched, break-away handle allows the head to be placed into the vial with minimal handling and contamination.
4.100% polypropylene handle ensures no additional contaminants are introduced and provides excellent chemical resistance labels
5.Cleanroom compatible for vial sample identification and traceability. Container/Box
6.Double bagged and packed in a cleanroom compatible polypropylene
Labels:Cleanroom compatible for vial sample identification and traceability.
Container/Box :Double bagged and packed in a cleanroom compatible polypropylene

Preparation for Total organic carbon (TOC) Testing:
(1) Confirm equipment is clean and operator is gowned properly for testing (clean gloves,face mask, gown, hairnet, clean environment).
(2) Take “cleaned” low TOC swabs and break tip off in a certified low TOC vial.
(3) Fill the vial with 40 mL of ultrapure, low TOC water and seal.
(4) Vortex vial for 15 seconds.
(5) Fill another empty certified low TOC vial with 40 mL of ultrapure, low TOC water and seal. This will be used as a “control blank”.
(6) Run the “control blank”hrough the TOC testing instrument to quantify the vial and water levels. Measurements should be taken in μg/L.
(7) Run the vial, with the swab inside, through the TOC testing equipment. Measurement should be taken in μg/L
(8) Subtract the “control blank” from the swab vial to get final measurement. All measurements should be taken inμg/L. Our goal is to be less than 50 μg/L.

TOC

test

 

Specifikace

Jednotky

Výsledek

 

Total Organic Carbon: Swabs

<50 μg / l

μg / l

35

Collection steps of TOC Test:
1. Please consult your written SOPs for sampling instructions.
2. Dip the swab in solution.
3. Sample the area.
4. Remove the vial cap.
5. Snap the swab head by placing the swab head into the vial with the notch touching the top of vial. Avoid touching the swab head.
6. Replace the cap.
7. Label the sample.

Všechny naše výrobky jsou prvotřídní, zatímco sterilizace je v souladu s touto nebo třídou 2.
Excpept UV záření a ozónu sterization v naší GMP rozhodl továrnu, a všechny výrobky jsou sentr třetím osobám pro ozařování sterilizaci
Níže je zpráva o sterilizaci ozáření:

Jako první čínská továrna, která je certifikována FDA, na testovací sadě DNA, Huachenyang je nyní vedoucí značkou genetického testu spotřebního materiálu v Číně,
Jediný s certifikátem FDA, CE, Free certificate a exportní licenci založenou na GMP
V srpnu 2013, CE odměňoval;
V prosinci 2014 schválila agentura FDA;
V lednu 2018 vydal nový prodej zdarma na základě GMP.
V červnu 23rd 2018 byla vydána výrobní licence třídy Medical 2 Medical Device

Chcete-li potvrdit náš certifikát FDA, prosím laskavě Klikněte zde: US Food and Drug Administration