공정 도전 장치
Steam용 테스트 팩 PCD(이동 전면 통합 장치 포함)
오토클레이브 모니터링용 이동식 전면형 5형 화학 지시약을 갖춘 공정 점검 장치.
SKU: PCD26-C
카테고리
: 공정 도전 장치
브랜드: Integron®
기술설명
상품 유형
PCD26‑C Integron® Process Challenge Device (PCD) with IT26‑C Chemical Integrator
주요 응용
Monitoring steam sterilization cycles in both dynamic‑air‑removal (vacuum assist) and gravity displacement autoclaves; ensures routine monitoring and sterilizer qualification testing
주요 이점
Provides visible migration front with ACCEPT/REJECT zones to confirm sterilization efficacy; incomplete migration indicates penetration failure and prevents load release
기술/차별화 요소
- Porous card system containing IT26‑C Chemical Integrator (Type 5, ISO 11140‑1 compliant)
- Self‑adhesive Record Card (PCD26‑C‑RC) for documentation of sterilization cycle data
- Cardboard box (10.5 × 6.5 × 1.8 cm) with Type 1 Process Indicator printed on the surface
- Process Indicator: blue → dark grey/black
- Chemical Integrator: migration front visible, calibrated against kill time of Geobacillus stearothermophilus spores
- FDA 510(k) cleared (K191021) and ANMAT authorized (PM‑1614‑4)
호환성/사용 환경
- United States: Gravity displacement (121 °C, 30 min) / Dynamic air removal (132 °C, 4 min)
- Outside US: Gravity displacement (≥30 min at 121 °C) / Dynamic air removal (≥4 min at 132–135 °C)
- Not suitable for EO, dry heat, or other sterilization methods
