神戸バイオロボティクス株式会社

日本語

Production environment

clean room

■ ISO14644-1:2015(International Standard - [cleanliness evaluation]) Production in Class 6 and Class 7 clean rooms

Maintaining cleanliness

■ Periodic particle counter (particulate counter)
■ Compliance with ISO 21501-4

Maintain product quality

■ The temperature, humidity, and other environmental conditions in the clean room are maintained at a constant level.

Manufacturing Method

We require our workers to maintain thorough hygiene, including their clothing.

Mold

Manufactured by two types of injection molding machines: two-color molding machine and single-color molding machine.

〇Production equipment is regularly maintained to ensure quality

TUBE main body uses two-color molding machine

Injection Molding Machine

Caps and Racks use mono-color molding machine.

単色成形機でキャップやラックなどの単色製品を製造しています

Processing

Processing by automatic machines

Assembling work is performed on an automatic machine.

Assembly (TUBE, CAP, etc.)

Laser printing work is performed by an automatic machine

Laser printing

Material quality

Use only“Virgin PP” for TUBE
Virgin PP...non-recycled resin

advantage:
・Reduction of contamination risk
・Assurance of product consistency and quality
・Safe for long-term use

Raw materials are RoHS/REACH compliant.

advantage:
・Free of hazardous substances
・Safety
・Reduction of environmental impact at disposal

Quality test

Only products that have passed the following tests are shipped

Physical Surface Testing

Appearance Tests No burrs, sink marks, shorts, foreign matter, etc.
Dimension and weight measurement Maintaining the standards established for each product
Thread torque test Verification of optimal sealing conditions for caps and tubes
Autoclave durability test Torque change and leakage test of autoclaved products (121°C, 15 min)
Freezing Tests (Weight change, shape change) -30,-80,-150°C freezer use
Leak Test IATA (International Air Transport Association) compliant

Functional Testing

Chemical Resistance Test General chemical resistance
Elution test Confirmed by GC/MS, LC/MS, ICP/MS
Low adsorption test
(DNA, Protein)
Measurement of the amount of a substance adsorbed to a surface
Cytotoxicity test Ensure that the material is not harmful to living organisms
2D Code Printing Evaluation Test valuation basis
ISO/IEC TR29158:2011
ISO/IEC 16022:2006

Biological contaminants

Our products do not contain the following contaminants

DNase(Deoxyribonuclease)

Enzymes that degrade DNA

RNase(Ribonuclease)

Enzymes that degrade RNA

Pyrogen(Exothermic substance)

Adverse effects on the human body and cellular experiments

Human DNA(human-derived deoxyribonucleic acid)

Adverse effects in molecular biological experiments and clinical trials

Animal(Animal-derived ingredients)

Disruption of genetic analysis, interference with protein experiments, etc.