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견적 요청

HIAC 9703+ 불용성 미립자 계수기

1mL에서 1000 mL 이상까지 처리가능한 HIAC 9703+ 액체 입자 계수기는 미리 제공된 USP/EP/JP/KP 시험법을 통하여 사용자의 모든 응용분야의 요구 사항을 충족할 수 있습니다. 사용자는 HIAC 9703+로 자동 세척 기능 및 테스트 레시피 설정 마법사를 사용하여 더욱 편리하게 장비를 사용할 수 있습니다.

PharmSpec 소프트웨어는 21 CFR Part 11 환경의 데이터 보안을 제공합니다.
자동 데이터베이스 백업 및 복구 손실 기능으로 중요 결과 데이터 보호
전문적인 SOP 및 IQ/OQ 검증 서비스 제공

관련문서 및 응용분야자료

HIAC 9703+ 불용성 미립자 계수기 제품 특징

응용분야

Small Volume Injectable (SVI)
Large Volume Injectable (LVI)
연구 개발
문제 해결
안정성 테스트

샘플 관리

즉각적인 입자 오염 알림
고가의 샘플은 소형 바이알 홀더를 사용하여 소량 샘플 측정 가능
유량의 다양한 설정과 교체가능한 센서의 제공을 통하여 0.5 µm - 600 µm 입자 크기 측정이 가능
교체 가능한 샘플 프로브 및 주사기

소프트웨어

표준 시험법 (주사제, 점안제, 흡입제) 이 내장되어 있어 수동 계산이 불필요
21 CFR Part 11 준수를 위한 다양한 보안 수준
자동 데이터베이스 백업 및 복구 손실 기능으로 중요 결과 데이터 보호

지원

전문적인 SOP 및 IQ/OQ 검증 서비스 제공
운용시간을 극대화할 수 있는 신속한 현장 서비스
ISO 21501을 준수하는 교정

HIAC 9703+ 불용성 미립자 계수기 제품 사양

Software	PharmSpec 3
Industry Standards	CE
Light Source	Long Life laser diode with 10 year mean-time-to-failure
Particle Size Analysis Range	0.5 - 600 μm
Concentration Range	0 to 18000 particles/mL

Operating System	Windows® XP with Service Pack 3 or later; Windows® Vista with Service Pack 2 or later; Windows® 7 (32 bit)
Software	PharmSpec 3
Temperature Range	Operating temp range: 5^°C to 40^°C
Item Specifications Referenced	2089105-01

샘플 측정 방법

HIAC 9703+ 불용성 미립자 계수기 관련 문서

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Title	Description
Automating Biopharma Quality Control to Reduce Costs and Improve Data Integrity	This whitepaper takes a look at four common quality control procedures and how automation can help improve data integrity by reducing opportunities for human error, whilst also saving time and reducing operating costs.
Quality Control Electronic Records for 21 CFR part 11 Compliance	This paper describes how Quality Control instruments can be optimised for pharmaceutical use, helping to improve the integrity of the data in the final electronic record.
21 CFR Part 11 QC Instrument Suite {279C6CA2-9797-4CFE-9CAA-5EAFAC29B60D}	This datasheet outlines QC steps, instruments, applications, regulations, and ALCOA compatibility.
Certified HIAC Calibration Services {9E29D7A5-B5EC-470A-A5C1-4EF9BFAE9959}	ISO 11171 & 21501-3 calibration services for your HIAC liquid particle counter
Quality Control Testing Instrumentation Solutions for GMP Manufacturing Brochure {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	Brochure on instruments designed for Raw Materials QC, Production QC, and Final Product QC
【カタログ】ラボ型液中パーティクルカウンター HIAC 9703+ {A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}	光遮蔽粒子計測のパイオニアとして、55年以上の長きにわたりグローバルスタンダードとしてお客様をサポートしています。
HIAC 9703 Win 10 Update Letter {749D68FB-4893-4B2D-BD6C-C662F0520F64}
ALCOA+ Infographic	Guidance on Maintaining Data Integrity Infographic
Automating Quality Control Testing for Improved 21 CFR Part 11 and ALCOA Data Integrity {A0D0EF0B-43F2-431C-BEB0-69F98765BDC4}	Infographic showing manual to automated - how our QC Suite instruments help you comply with 21CFR part 11 ALCOA
Achieving Compliant Batch Release – Sterile Parenteral Quality Control {442DF88C-CA7F-4B78-AF75-9D2B985534C0}
Final Product Quality Testing
Quality Control Electronic Records for 21 CFR part 11 Compliance {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper describes how Quality Control instruments can be optimised for pharmaceutical use, helping to improve the integrity of the data in the final electronic record.
Automating Biopharma Quality Control to Reduce Costs and Improve Data Integrity {442DF88C-CA7F-4B78-AF75-9D2B985534C0}	This paper takes a look at four common quality control procedures and how automation can help improve data integrity by reducing opportunities for human error, whilst also saving time and reducing operating costs.
Maintaining Data Integrity: Understanding FDA ALCOA Guidance	21 CFR part 11 ALCOA defines good data integrity practice as creating records that are attributable to the technician carrying out the testing, are legible, are created contemporaneously, original and accurate.

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