Isoclean® Healthcare Platform Isolator (HPI) Sets Foot in the Land of Uncle Sam
Esco Pharma Division has recently delivered and installed 3 units of Isoclean HPI in one of the biggest biotechnological companies in USA, with 17 more coming this year 2018. Installation Qualification (IQ) and Operation Qualification (OQ) has been completed, but in an unclassified environment due to client confidentiality and will be later transferred to a cleanroom. The positive pressure Isoclean HPI with recirculating airflow and Type D pass chambers is the model of choice for regenerative medicine applications (also known as Advanced Therapy Medicinal Products in Europe).
Successfully conforming the requirements for safety, Isoclean HPI was granted UL certification which will give end users additional confidence in choosing the best equipment for their application.
Isoclean HPI is designed in accordance with international Current Good Manufacturing Practice (cGMP) standards. It is equipped with supply HEPA (H14) filters providing ISO Class 5 environment suitable for aseptic processing of cell - and tissue-based therapies. The Type D pass chambers have interlocked doors, adjustable purged duration, and time-delayed ingress/egress control allowing sufficient time for surface decontamination to minimize transfer of contamination.
Isoclean HPI is capable of being pressure tested both in the factory and on-site to meet the ISO 10648-2 standards. The system is capable of giving real-time pressure readings during operation for monitoring purposes. It is also equipped with glove port covers made of medical grade plastic with FDA-approved static seals. The integrity of the gloves can be measured quantitatively, applying the pressure decay method.
Aside from cell and tissue processing applications, Isoclean HPI is also offered as an optimized solution for sterility testing, pharmacy compounding, and biocontainment, among others. The isolator is available as a standard unit or as a customized unit to integrate various equipment such as CO2 incubator, centrifuge, BioVap™ biodecontamination system providing a complete and simplified workflow processing.
Esco Pharma boasts its strengths on multiple manufacturing sites – Singapore, United Kingdom, and the United States, allows them to serve customers globally. These three locations utilize the same engineering standards to cater the international market and produce quality equipment with components which are available internationally. Fully certified by ISO 9001, 14001 18001, 13485, Esco is the only company with distributed manufacturing sites for isolators but with direct sales and service support from 25 local Esco offices.
- UL Online Certifications Directory. Retrieved from http://database.ul.com/cgi bin/XYV/template/LISEXT/1FRAME/showpage.html?name=OGTK.E248249&ccnshorttitle=Laboratoryuse+Electrical+Equipment&objid=1077446615&cfgid=1073741824&version=versionless&parent_id=1073990662&sequence=1.Accessed 12/27/2017.