Clean validation kits

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TOC Cleaning Validation Kit CY-3340

Large tip Sampling swab / Cleaning Validation swab replace Texwipe TX715

The TOC analysis of swab samples for the cleaning validation of fermentation equipment used in the pharmacy production,is conducted to substantiates the effectiveness of a cleaning process and verify that no residue remains(from a previously manufactured product or from disinfectants and cleaning solutions) on the surfaces of biopharmaceuticals production equipment, to ensure that undesirable compounds are not transfer from one batch to a new product batch using the same manufacturing equipment.

Application:

 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.

TOC Clean Validation swab dimension:

TOC Clean validation kit:

Product Name

TOC Cleaning Validation Kit---CY-3340

Patent No. In China

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

Certificate

FDA,CE,EU,Free Sale,Export license based on (GMP)

Application

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.

TOC Clean validation kit content

 

12pcs 40 mL clear vials bonded septa caps, certified <10 µg/L TOC

24pcs CY-715A Low TOC iCleanhcy® Swab with Long Handle, certified <50 µg/L TOC

12 blank vial labels

Sterility

Sterile

Storage

Room Temperature (15-30)

Pack

18 kits/Case

Shelf life

3 year

Capacity

480,000 kits/15 days

OEM/ODM

Customization of design,color, logo,pack,swab shape & break point

Lead Time

12-18 days from deposit

MOQ

2 Cases

Payment

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

Shipping

By sea,by air, by Express DHL,Fedex,UPS or 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

 

Specifications

Units

 Result

 

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.

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:

As FDA certified first Chinese factory on DNA test kit, Huachenyang now is leading brand of genetic test consumable in China,
the only one with FDA,CE,Free certificate, and export license based on GMP
In Aug. 2013, CE rewarded;
In Dec. 2014, FDA approved;
In Jan. 2018, New Free Sale based on GMP issued.
In 23rd June 2018, Production License of Class 2 Medical Device Issued

To confirm our FDA certificate, please kindly click here: U.S. Food and Drug Administration