材料
polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal
品質等級
法律遵循
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
製造商/商標名
Opticap®
參數
25 °C max. inlet temp.
80 psig max. inlet pressure
柱標稱長度
30 in. (75 cm)
入口接頭直徑
1.5 in.
出口接頭直徑
1.5 in.
雜質
≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
重量法萃取物
≤165 mg/capsule
基質
Polygard®-CN
孔徑
1.2 μm nominal pore size
1.2 μm pore size
輸入
sample type liquid
接頭
inlet sanitary flange
38 mm (1 1/2 in.) inlet/outlet sanitary flange
outlet sanitary flange
相關類別
一般說明
Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line
特點和優勢
Format: Single Layer
包裝
Double Easy-Open bag
其他說明
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use
- Organism Retention: Microorganism reduction
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
準備報告
Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
分析報告
Gravimetric Extractables: after 24 hours in water at controlled room temperature
法律資訊
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
分析證明 (COA)
輸入產品批次/批號來搜索 分析證明 (COA)。在產品’s標籤上找到批次和批號,寫有 ‘Lot’或‘Batch’.。
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