meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
製造商／商標名
Opticap®
參數
1.0 bar max. inlet pressure (15 psi) at 80 °C 2.75 bar max. inlet pressure (40 psi) at 60 °C 25 °C max. inlet temp. 4.8 bar max. differential pressure (70 psid) at 20 °C 5.5 bar max. inlet pressure (80 psi) at 23 °C 80 psig max. inlet pressure
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use
Organism Retention: Microorganism
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
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
分析報告
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
法律資訊
CLARIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
免責聲明
EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
