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Cleaned Vials for TOC and other Critical Applications
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Available Container Processing
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Silanization & Siliconisation & Particle Cleaning
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Process
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Common Applications
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Description
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Proteins, assays of blood serum, pharmacological assays of therapeutic drugs |
Silanizing neutralizes active sites in glassware. This prevents the sample to react with active sites in the glass. |
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Proteins, assays of blood serum, pharmacological assays of therapeutic drugs |
Siliconized products are physically coated with medical-grade silicone emulsion to prevent the sample to react with active sites in the glass. |
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Numerous applications in the pharmaceutical, biotech, medical, semiconductor industries, and anywhere cleanrooms or controlled environments are utilized |
17 MOhm reines, electronics-grade water fi ltered to sub-micron levels is heated and used for the particulate cleaning process. |
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TOC & VOC certifi edt & USP Purifi ed Water and WFI Rinses
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Process
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Common Applications
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Description
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Validation of water systems and cleaning validations, TOC trace analyisis |
Total organic carbon (TOC) is a measure of the amount of carbon covalently bound in organic molecules in a water sample. |
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Trace analysis of volatile organic compounds (VOC) |
Cleaning following EPA Protocol „B“ |
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Clean Room Applications in the pharmaceutical, biotech, medical, and semiconductor industries |
Für den Nachweis kleinster TOC Gehalte beispielsweise in Pharmawässern: Reinigung mit Reinstwasser und WFI Spülung für pyrogenfreie oder sterile Behältnisse. |
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Sterilization
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Process
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common Applications
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Description
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Injectable or parenteral drugs, lyophilization, final packaging prior to drug delivery, stability studies |
Sterilization involving steam, heat and pressure to destroy all viable forms of life, including bacterial spores to an acceptable sterility assurance level (SAL) of 10-6 |
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Injectable or parenteral drugs, lyophilization, final packaging prior to drug delivery, stability studies, clinical trials |
A radiation dose suffi cient to destroy all viable forms of life including bacterial spores, is applied to an acceptable sterility level (SAL). A typical radiation dose is 25-40 kGy, which produces the required SAL of 10-6 |
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Injectable or parenteral drugs, stability studies, clinical trials |
Sterilization via a validated dry-heat, foil-wrap method. Stoppers and seals are sterilized via autoclave methods. |
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Injectable or parenteral drugs, Lyophilization, final packaging prior to drug delivery, stability studies, clinical trial |
Depyrogenation destroys and removes Endotoxines. Endotoxines are fever producing substances which are found in the cell wall of certain bacteria. Depyrogenated products have reduced endotoxin content by at least 99.9%. |
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molecular biology, in the pharmaceutical medical research fields |
Ribonuclease, is a nuclease that catalyzes the hydrolysis of RNA into smaller components. RNase A for example is one of the hardiest enzymes in common laboratory usage. Nucleases are omnipresent contaminates in the laboratory environment today, and while bacterial contamination is still a major concern for molecular biologists in the pharmaceutical and medical research fi elds, sterilization methods such as gamma irradiation and autoclaving do not remove RNase, DNase and pyrogens. |
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© infochroma ag, Sumpfstrasse 3, CH-6300 Zug; Tel: +41 41 748 50 60, info@infochroma.ch
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