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BioSafety Kit
Product Listing
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Description:
MycoFinder: sensitivity, simplicity, and speed MycoFinder is a Real-Time PCR cell culture contamination detection kit that provides a sensitive, rapid, reliable, and cost-effective solution for the quality control of Advanced Therapy Medicinal Products (ATMPs) and biopharmaceuticals. MycoFinder rapid mycoplasma cell culture contamination detection kit, has been validated in accordance with the EP 2.6.7, USP 63 and JP 17 and is available throughout EMEA. MycoFinder uses real-time fluorescent PCR to ensure sensitive mycoplasma detection (below 10 CFU/mL). The kit is simple and quick to implement for product screening and batch release in laboratories where time is of the essence.
OUT OF STOCKMycoFinder: sensitivity, simplicity, and speed MycoFinder is a Real-Time PCR cell culture contamination detection kit that provides a sensitive, rapid, reliable, and cost-effective solution for the quality control of Advanced Therapy Medicinal Products (ATMPs) and biopharmaceuticals. MycoFinder rapid mycoplasma cell culture contamination detection kit, has been validated in accordance with the EP 2.6.7, USP 63 and JP 17 and is available throughout EMEA. MycoFinder uses real-time fluorescent PCR to ensure sensitive mycoplasma detection (below 10 CFU/mL). The kit is simple and quick to implement for product screening and batch release in laboratories where time is of the essence.
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Description:
BactFinder™/FungiFinder™ Rapid microbiological testing for bacteria and fungi Two protocols: rapid test method and high sensitivity test method Product Features • Nucleic acid amplification (NAT) reagents for highly sensitive and simple testing • Target specific reagents are not easily inhibited by human nucleic acids • Covers many microorganisms, including not only pharmacopoeia but also environmental and human-derived • Two original protocols (rapid test method and high sensitivity test method) Operations Product Information Product Name BactFinder™/FungiFinder™ Sample Types Cell suspensions, culture supernatant Limit of Detection (LOD) Rapid test method : 100 CFU/sample High sensitivity test method : < 10 CFU/sample Specificity Target-specific detection (No cross-reactivity with human genome) Detection Time Rapid test method : Within 4 hours High sensitivity test method : Pretreatment + Within 4 hours Number of reactions per Kit 50 Storage Temperature -30 to -15°C Performance Evaluation Data Rapid test method and High sensitivity test method using BactFinder™/FungiFinder™ are tested for detection sensitivity. Rapid test method The rapid test method was detected 100% of the six microorganisms at 100 CFU/mL in the European and Japanese pharmacopoeias. Microorganism strain Detections / tests Aspergillus brasiliensis ATCC 16404 8/8 Candida albicans ATCC 10231 8/8 Bacillus subtilis subsp. spizizenii ATCC 6633 8/8 Clostridium sporogenes ATCC 11437 8/8 Pseudomonas aeruginosa ATCC 9027 8/8 Staphylococcus aureus ATCC 6538 8/8 High sensitivity test method The high sensitivity test method was detected 12 microorganism, including those listed in European and Japanese pharmacopoeias, within 48 hours. Microorganism strain CFU 24 h 48h Stenotrophomonas maltophilia ATCC 13637 0.3 + Bacillus licheniformis ATCC14580 2 + Brevibacterium casei ATCC 35513 0.3 + Yersinia enterocolitica ATCC 9610 8 + Pseudomonas fluoresens ATCC 13525 11 + Enterococcus hirae ATCC 8043 3 + Escherichia coli ATCC 8739 3 + Salmonella enterica subsp. enterica ATCC 14028 9 + Strepococcus pyogenes ATCC 19615 5.5 + Micrococcus luteus ATCC 14452 3.5 NA + Penicillium rubens ATCC 9787 8.5 NA + Cutibacterium acnes ATCC 11828 1.5 NA +
OUT OF STOCKBactFinder™/FungiFinder™ Rapid microbiological testing for bacteria and fungi Two protocols: rapid test method and high sensitivity test method Product Features • Nucleic acid amplification (NAT) reagents for highly sensitive and simple testing • Target specific reagents are not easily inhibited by human nucleic acids • Covers many microorganisms, including not only pharmacopoeia but also environmental and human-derived • Two original protocols (rapid test method and high sensitivity test method) Operations Product Information Product Name BactFinder™/FungiFinder™ Sample Types Cell suspensions, culture supernatant Limit of Detection (LOD) Rapid test method : 100 CFU/sample High sensitivity test method : < 10 CFU/sample Specificity Target-specific detection (No cross-reactivity with human genome) Detection Time Rapid test method : Within 4 hours High sensitivity test method : Pretreatment + Within 4 hours Number of reactions per Kit 50 Storage Temperature -30 to -15°C Performance Evaluation Data Rapid test method and High sensitivity test method using BactFinder™/FungiFinder™ are tested for detection sensitivity. Rapid test method The rapid test method was detected 100% of the six microorganisms at 100 CFU/mL in the European and Japanese pharmacopoeias. Microorganism strain Detections / tests Aspergillus brasiliensis ATCC 16404 8/8 Candida albicans ATCC 10231 8/8 Bacillus subtilis subsp. spizizenii ATCC 6633 8/8 Clostridium sporogenes ATCC 11437 8/8 Pseudomonas aeruginosa ATCC 9027 8/8 Staphylococcus aureus ATCC 6538 8/8 High sensitivity test method The high sensitivity test method was detected 12 microorganism, including those listed in European and Japanese pharmacopoeias, within 48 hours. Microorganism strain CFU 24 h 48h Stenotrophomonas maltophilia ATCC 13637 0.3 + Bacillus licheniformis ATCC14580 2 + Brevibacterium casei ATCC 35513 0.3 + Yersinia enterocolitica ATCC 9610 8 + Pseudomonas fluoresens ATCC 13525 11 + Enterococcus hirae ATCC 8043 3 + Escherichia coli ATCC 8739 3 + Salmonella enterica subsp. enterica ATCC 14028 9 + Strepococcus pyogenes ATCC 19615 5.5 + Micrococcus luteus ATCC 14452 3.5 NA + Penicillium rubens ATCC 9787 8.5 NA + Cutibacterium acnes ATCC 11828 1.5 NA +
