Precleaned vials critical applications - a description of possible cleaning procedures

Silanisation & Siliconisation & Particle Cleaning

Procedure typical application description
Silanisation Proteins, assays of blood serum, pharmacological assays of therapeutic drugs Silanising neutralizes active sites in glassware. This prevents the sample to react with active sites in the glass.
Siliconisation Proteins, assays of blood serum, pharmacological assays of therapeutic drugs Siliconised products are physically coated with medical-grade silicone emulsion to prevent the sample to react with active sites in the glass.
Particle Cleaning Numerous applications in the pharmaceutical, biotech, medical, semiconductor industries, and anywhere cleanrooms or controlled environments are utilized 17 MOhm pure, electronics-grade water filtered to sub-micron levels is heated and used for the particulate cleaning process.
TOC & VOC certified & USP Purified Water and WFI Rinses
Procedure typical application description
TOC Validation of water systems and cleaning validations, TOC trace analysis Total organic carbon (TOC) is a measure of the amount of carbon covalently bound in organic molecules in a water sample.
VOC Trace analysis of volatile organic compounds (VOC) Cleaning following EPA Protocol „B“
USP Purified Water
and WFI Rinses
Clean Room Applications in the pharmaceutical, biotech, medical, and semiconductor industries For the detection of smallest TOC contents e.g. in pharmaceutical waters: rinsing with purest water and WFI rinse for depyrogenated or sterile containers
Sterilisation
Procedure typical application description
Steam Sterilization Injectable or parenteral drugs, lyophilisation,
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
Irradiation Injectable or parenteral drugs, lyophilisation,
final packaging prior to drug delivery, stability
studies, clinical trials
A radiation dose sufficient 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
Sterile Foil-Wrap 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.
Depyrogenation
validated 3-log
reduction
Injectable or parenteral drugs, Lyophilisation,
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 a reduced endotoxine content by at least 99.9%.
RNase & DNase molecular biology, in the pharmaceutical medical
research fields
Ribonuclease, is a nuclease that catalyses 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 fields, sterilization methods such as gamma irradiation and autoclaving do not remove RNase, DNase and pyrogenes
Index
Description of
cleaning procedures
Silanised vials
Sterile & cepyrogenated
vials
TOC vials
VOC vials
for pesticide or metal,
cyanide, sulfide, fluoride
or nitrate/nitrit analysis
 
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