아이솔레이터 다양한 제품군 (diverse compounding pharmacy isolators)


Oct 25, 2016

아이솔레이터 다양한 제품군 (diverse compounding pharmacy isolators)

TaPestle Rx (Esco Healthcare 부서)는 점차 엄격해지고 있는 pharmacy compounding(503A and 503B) 분야의 기준에 맞는 다양한 아이솔레이터 제품을 런칭하였습니다.

다양한 제품군(Isolator)

Esco Isolator는 제품선택의 폭이 넓으며 보다 합리적인 가격으로 원하는 어플리케이션에 적합한 제품을 제공하고 있습니다.

First to LEAD and last to FOLLOW

Esco는 40년 넘게 실험장비를 제작하였으며 미국 제약(Pharmacy compounding)시장에 cGMP-compliant isolators를 처음 런칭하며 클린공기분야 전문기업으로서 실력을 인정받고 있습니다.

 

주요 특징

Esco isolator 는 pharmaceutical industry 및 pharmacy compounding applications에 적합한 제품입니다. 모든 제품은 503A/503B facilities 조건을 충족하며, USP 797/800 와 FDA cGMP standards에 맞게 제작되었습니다.

  • Pressure testing to Class 2 containment enclosure as described by ISO 10648-2 standard, which can be done on-site without using blanking plates and silicone. HPI 압력 테스트 비디오(See video on HPI Pressure Testing)
  • Full unidirectional airflow across entire workzone with 0.45 m/s ± 20%* providing ISO Class 5 (Grade A) environment
  • 316L stainless steel interior surface with 19-mm radius coved ball corners on all four sides* for easy cleaning and high-resistance to hydrogen peroxide vapor
Pressure testing with plates and silicone
  • Smooth, crevice-free, FDA-compliant glove ports, gaskets, and static seals allow easy cleaning with minimal trapping of contaminants
  • Optional integrated Esco BioVap™ hydrogen peroxide biodecontamination system validated to 6 log reduction of bio-burden
  • Glove leak testing using pressure decay method quantitatively measures pinhole leakages
  • Bag-In-Bag-Out and Low Contamination filter changes in isolators ensures operator and environment protection during a filter change.

Esco Technologies, Inc will be showcasing this range of isolators in the upcoming ASHP Midyear Clinical Meeting 2016 in Las Vegas on December 04-08, 2016. Come and meet our team at Booth #471 to discuss your application and specific compounding needs.

*not available on all models

 

궁금하신 점이나 문의사항은 아래 연락처로 연락하시기 바랍니다::

Esco

[email protected]

Tel: 02 830 0482 

Fax: 02 830 0491

 

or

TaPestle RX

A division of Esco Healthcare

[email protected]

+65 6542 0833