

- COMPOUNDING ASEPTIC ISOLATOR FULL
- COMPOUNDING ASEPTIC ISOLATOR SOFTWARE
- COMPOUNDING ASEPTIC ISOLATOR ISO
COMPOUNDING ASEPTIC ISOLATOR ISO
Meets USP 797 standards by providing an ISO 5 environment for compounding.Thermo Fisher Scientific (Asheville) LLC.

The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. The cookie is used to store the user consent for the cookies in the category "Performance". This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary". The cookie is used to store the user consent for the cookies in the category "Other. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". The cookie is used to store the user consent for the cookies in the category "Analytics". These cookies ensure basic functionalities and security features of the website, anonymously. Necessary cookies are absolutely essential for the website to function properly. Jacomex can also supply customised aseptic drug preparation isolators with accessories and options to meet the strict requirements of your preparations. Your operational costs will also be reduced, as their maintenance and upkeep is also reduced. Taking up less space, the isolators reduce your renovation costs for a low investment. The traceability of the products in each stage of preparation is also proven with the help of the documents provided by the company. During inspections by the authorities, the data collected is of great use. It is also easy to record and adjust humidity levels, temperatures and pressures.
COMPOUNDING ASEPTIC ISOLATOR SOFTWARE
The integration of software and options makes it easy to control and monitor drug preparations. Compared to sterile cleanrooms, isolators offer a far superior sterile environment, with particularly effective aseptic processes, procedure validation and sterility testing. Isolators are a modern piece of technology from which the pharmaceutical industry can benefit.
COMPOUNDING ASEPTIC ISOLATOR FULL
Side-by-side or face-to-face workstations, as required.įor drug preparations, Jacomex ensures that the isolator is designed in full compliance with GAPMP5, ISO and PIC/S, 21 CFR PART 11, GMP and FDA standards.Tight flow with or without internal storage.Laminar, unidirectional or turbulent flow ventilation.Isolators for the preparation of medicines that the company can provide have the following general characteristics: Jacomex designs and manufactures containment equipment for various sectors, including the pharmaceutical sector. Characteristics of Jacomex Aseptic Isolators The isolator must ensure compliance with all the requirements dictated by each preparation of advanced therapy medicinal products, each dosing and weighing operation, etc. The isolator and all accompanying equipment must be sterilized. The isolator incorporates transfer systems for the introduction and removal of prepared drugs and for the disposal of waste materials under aseptic conditions. In all cases, the purpose of using an isolator is to protect drug preparations from contaminants. Depending on how it is used, the isolator offers a controlled atmosphere zone with laminar air flow or operates in overpressure or underpressure. The equipment enables the preparation of medicines in aseptic air and in a controlled and purified atmosphere. This can be integrated into a vacuum or overpressure isolator.įor aseptic applications, such as drug preparation, the use of an isolator is the best solution due to its performance. Isolators are also equipped with HEPA filters upstream and downstream and a ventilation system. The integrity of these walls must be checked regularly to ensure that there are no leaks and that the main chamber is completely sealed. Aseptic drug preparation isolators are made up of walls.
