material
PVC tubing
mixed cellulose esters (HA) membrane
stainless steel needle
styrene-acrylonitrile (SAN) (canister)
Quality Level
Agency
ChP
무균
sterile; γ-irradiated
제조업체/상표
SteriSecure™
파라미터
max. pressure at 3.15 bar and 25 °C
45 °C max. temp.
길이
850 mm
공극 크기
0.45 μm (Canister membrane)
입력
liquid
응용 분야
pharmaceutical
sterility testing
호환성
for use with Steritest® systems
일반 설명
The SteriSecure™ Device for ampoules and bags is designed for sterility testing of large volume parenterals and synthetic drugs. The SteriSecure™ Device for liquids in ampoules or collapsible bags includes a single needle for easy access to ampoules and a separate vent needle.
The closed system minimizes false positives and offers the highest level of quality and reliability. This device ensures that pharmaceutical products are never exposed to the environment during the testing process. This membrane provides an optimal filtration flow rate for standard products. This test system offers an optimized and fully regulatory compliant testing process when used with the Steritest® Symbio pump, specific accessories, and high-quality culture media and rinsing fluids.
The closed system minimizes false positives and offers the highest level of quality and reliability. This device ensures that pharmaceutical products are never exposed to the environment during the testing process. This membrane provides an optimal filtration flow rate for standard products. This test system offers an optimized and fully regulatory compliant testing process when used with the Steritest® Symbio pump, specific accessories, and high-quality culture media and rinsing fluids.
애플리케이션
The SteriSecure™ Device for ampoules and bags is used during the testing of pharmaceutical products in ampoules or collapsible bags for streamlining the workflow and increasing safety during sterility testing.
법적 정보
STERISECURE is a trademark of Merck KGaA, Darmstadt, Germany
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
Storage Class Code
11 - Combustible Solids
WGK
WGK 3
시험 성적서(COA)
제품의 로트/배치 번호를 입력하여 시험 성적서(COA)을 검색하십시오. 로트 및 배치 번호는 제품 라벨에 있는 ‘로트’ 또는 ‘배치’라는 용어 뒤에서 찾을 수 있습니다.
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