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सफा प्रमाणीकरण स्वाब

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TOC सफाई प्रमाणीकरण किट 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.

आवेदन:

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:

उत्पादन नाम

TOC Cleaning Validation Kit---CY-3342

प्याटेन्ट नम्बर चीनमा

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

प्रमाणपत्र

एफडीए, सीई, ईयू, नि: शुल्क बिक्री, निर्यात मा आधारित लाइसेन्स (जीएमपी)

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

आवेदन

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.

स्टेरिलिटी

बाँझ

भण्डारण

कक्ष तापमान (15-30)

पैक

18 kits/Case

आफ्नो जीवन

1 वर्ष

क्षमता

480,000 kits/15 days

OEM / ODM

डिजाइन, रङ, लोगो, प्याक, स्वाब आकार र ब्रेक बिन्दु अनुकूलन

नेतृत्व समय

जम्मा देखि 12-18 दिन

MOQ

2 कारणहरू

अनलाइन भुक्तानी

एल / सी, टी / टी, मनी ग्राम, एस्को, पेपैल, वेस्टर्न यूनियन, डीडीपी, डीएपी

शिपिंग

समुद्र द्वारा, हावा द्वारा, एक्सप्रेस डीएचएल, फेडेक्स, यूपीएस वा TNT द्वारा

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

परीक्षण

 

निर्दिष्टीकरण

units

परिणाम

 

Total Organic Carbon: Swabs

<50 mg/L

mg/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.

All Our Products are class one, while we sterilization is adhere to that or Class 2.
Excpept the UV light & Ozone sterization in our GMP ruled factory, and all the products are sentr to third party for Irradiation sterilization
Below is Irradiation sterilization report:

जस्तै एफडीए डीएनए टेस्ट किटमा पहिलो चिनियाँ कारखाना प्रमाणित भयो, हाउचेन्याङ्ग अहिले चीनमा उपभोग्य आनुवंशिक परीक्षणको ब्रान्ड हो,
जीएमपीमा आधारित एफडीए, सीई, नि: शुल्क प्रमाणपत्र, र निर्यात इजाजतपत्र मात्र हो
अगस्ट। 2013 मा, सीई इनाम
डिसेम्बर 2014 मा, एफडीए अनुमोदन गरियो;
जनवरी मा 2018, जीएमपी जारी गरीएको नयाँ निशुल्क बिक्री।
23 जून जुन 2018 मा, कक्षा 2 मेडिकल उपकरण को उत्पादन लाइसेन्स प्रकाशित

हाम्रो एफडीए प्रमाणपत्र पुष्टि गर्न कृपया कृपया दयालु गर्नुहोस् यहाँ क्लिक गर्नुहोस्: US Food and Drug Administration

 

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