NEST, BioFactory 5 Chamber

āļĢāļŦāļąāļŠāļŠāļīāļ™āļ„āđ‰āļē : 771204

āļĢāļēāļ„āļē

0.00 āļŋ

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āļĢāļēāļ„āļēāļĢāļ§āļĄ 0.00 āļŋ

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āļŠāļīāļ™āļ„āđ‰āļēāļŦāļĄāļ”

NEST, BioFactory 5 Chamber


Strict product quality supervision

Production environment--Class 10,000 clean production workshop

NEST Factory is produced in a dedicated 10,000-class clean room, and other products are produced in a 100,000-class clean room.

Production material--Strictly selected polystyrene conforming to USP Class VI standard

Production Process--Strictly follow SOP for production and quality control

Exquisite product design, high precision forming, ultrasonic welding, no chemical addition.

Surface treatment--Tissue culture treated

The surface of the cell culture container is treated with hydrophilic treatment to ensure that the cells adhere to the surface more evenly and stable with better adsorption capacity.

Product expiration date verification

The cell growth surface can still meet the cell growth requirements after three years of aging, and there is no positive result of the sterility test.

Biosafety testing

Refer to <<State Food and Drug Administration National Standards for Packaging Materials and Containers in Direct Contact with Drugs

(Series 6)>>, The product is tested for cytotoxicity, sensitization, intradermal irritation, acute systemic toxicity and hemolysis.

Physical and chemical safety testing

Refer to <<State Food and Drug Administration National Standards for Packaging Materials and Containers in Direct Contact with Drugs

(Series 6)>>, The products are tested for insoluble particles, ignition residues, metal elements, and dissolved substances (clarity, color, pH, UV absorbance, non-volatile matter, easy oxides, heavy metals).

Process testing

In order to ensure the structure and strength of the product, it is necessary to verify the performance of relevant equipment, such as injection molding machines, molds, plasma equipment, welding machines, leakage meter and so on before production. After production, the product should be verified for sealing, strength, dropping and transportation.

Cell growth test

Cell growth homogeneity experiment.

Cell factory validation test--Sterility and particle guarantee

Product initial bioburden test, irradiation dose setting, dose review, aseptic packaging verification, irradiation process verification, product sterility and particle testing.

Applicable cells

VERO、MRC-5、2BS、293T、L-929 ......

Packaging strength verification

The breakage rate is less than 3% after repeated long distance delivery challenges.

Sterility Guarantee--Imported RhodotronÂŪ TT200 electron accelerator from Belgian IBA company, Self-built irradiation center.

The irradiation sterilization process has passed ISO 13485 and ISO 11137 quality system certification.

Feature

â€Ē Made of high clarity, 100% virgin polystyrene.

â€Ē Sterilized by E-beam, SAL=10-6.

â€Ē Non-Pyrogenic, DNase/Rnase free.

â€Ē Excellent welding line design can avoid producing particles during welding and make the biofactory stronger (Under Features 7th line).

â€Ē Vent caps with 0.22 Ξm hydrophobic filters for gas exchange without contamination.

â€Ē Wide mouth is applicable to pour culture medium directly. Narrow mouth is applicable to operate with the aseptic pipeline.

â€Ē Standardize operations to reduce batch differences. 

â€Ē Individually packaged in double-layer sterile bags.

â€Ē TC treated, good for cell attachment and growth.

â€Ē Clear lot number for batch traceability.

â€Ē Ultrasonic welding without extrinsic ingredients. 

â€Ē Standardize operations to reduce batch differences.

â€Ē Growth kinetics are the same as cells grow in the cell culture flasks. Applicable to large-scale culture adherent cells.

â€Ē Large growing area. Just a single operate, you can cultivate a large number of cells and reduce contamination risk.

â€Ē Applicable to automatic machine. 

āļĢāļēāļĒāļĨāļ°āđ€āļ­āļĩāļĒāļ”āļŠāļīāļ™āļ„āđ‰āļē

āļĢāļŦāļąāļŠāļŠāļīāļ™āļ„āđ‰āļē : 771204

āļ‚āļ™āļēāļ”āļŠāļīāļ™āļ„āđ‰āļē : 5 Layer

āļĒāļĩāđˆāļŦāđ‰āļ­ : NEST

Documents & Downloads

Certificate of Analysis "āļ„āļĨāļīāļāļ—āļĩāđˆāļ™āļĩāđˆ"

Certificate of Compliance "āļ„āļĨāļīāļāļ—āļĩāđˆāļ™āļĩāđˆ"

ïŧŋāļŠāđˆāļ­āļ‡āļ—āļēāļ‡āļāļēāļĢāļ•āļīāļ”āļ•āđˆāļ­


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