HIAC 9703+ 액체 입도 계수기

모든 샘플(1mL에서 1000 mL 이상까지 사전 구성된 USP/EP/JP/KP 테스트 루틴)을 처리 할 수 있는 HIAC 9703+ 액체 입도 계수기는 모든 작업의 요구 사항을 충족할 수 있습니다. 운영자는 HIAC 9703+로 자동 세척 루틴 및 테스트 레시피 설정 마법사를 사용하여 더욱 늘어난 여유 시간을 즐길 수 있습니다.

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

문서 및 작업 노트

HIAC 9703+ Liquid Particle Counter

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Choose a HIAC 9703 Plus Model

HIAC 9703+ Liquid Particle Counter Features

Applications

  • Small volume injectable (SVI)
  • Large volume injectable (LVI)
  • Research & development
  • Troubleshooting
  • Stability testing

Sample management

  • Instant particle contamination notification
  • Small vial holder preserves costly samples
  • Configurable flow rates & interchangeable sensors for 0.5 µm - 600 µm particle size detection
  • Interchangeable sample probes & syringes

Software

  • No manual calculation with pre-configured compendial test recipes (injectible drugs, ophthalmics, inhalants)
  • Multi-level security for 21 CFR Part 11 compliance
  • Automatic database backup & recovery loss feature protects valuable results data

Support

  • Expert SOP & IQ/OQ validation services available
  • Routine onsite service available for maximum uptime
  • ISO 21501 compliant calibrations

HIAC 9703+ Liquid Particle Counter Specifications

Industry Standards CE
Light Source Long Life laser diode with 10 year mean-time-to-failure
Particle Size Analysis Range 0.50|600.00|μm
Concentration Range 0.00|18,000.00|particles/mL
Item Specifications Referenced 2089105-01

Running a Sample

HIAC 9703+ Liquid Particle Counter Documentation

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Title Description
Quality Control Electronic Records for 21 CFR part 11 Compliance
{442DF88C-CA7F-4B78-AF75-9D2B985534C0}|{E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}
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}|{E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}
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. The four quality control procedures discussed in this paper form a common thread in the biopharmaceutical manufacturing industry and are water quality testing, cleanroom routine environmental monitoring, biological cell counting and viability testing and final injectable drug particulate testing.
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
Certified HIAC Calibration Services
{9E29D7A5-B5EC-470A-A5C1-4EF9BFAE9959}
ISO 11171 & 21501-3 calibration services for your HIAC liquid particle counter
21 CFR Part 11 QC Instrument Suite
{279C6CA2-9797-4CFE-9CAA-5EAFAC29B60D}
This datasheet outlines QC steps, instruments, applications, regulations, and ALCOA compatibility.
ALCOA+ Infographic
{A0D0EF0B-43F2-431C-BEB0-69F98765BDC4}|{9E29D7A5-B5EC-470A-A5C1-4EF9BFAE9959}
Guidance on Maintaining Data Integrity Infographic
Quality Control Testing Instrumentation Solutions for GMP Manufacturing Brochure
{A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}
Brochure on Raw Materials QC, Production QC, and Final Product QC product solutions


Technical Documents