I – Particle classification: Standard ISO 14644-1 and 2 2015 version After 10 years of discussion and no fewer than two DIS draughts, the two new parts 1 and 2 of ISO 14644 have just been published on the International Organization for Standardization (ISO) website. The revision process, which began in 2005, has resulted in significant… Read more »
Author: Justine Dubois
Belgium, an R&D paradise?
Julien Meyrat | 15 février 2016 | Almost one tenth of European pharmaceutical R&D investment in 2014 took place in Belgium. According to a study by pharma.be, almost one tenth of European pharmaceutical R&D investment in 2014 took place in Belgium (2.3 billion euros, second only to Denmark in terms of population). The country is… Read more »
The new ISO 14644-1 and -2 standards have been published!
The International Organization for Standardization has just published the two revised versions of parts 1 and 2 of the ISO 14644 standard. After ten years of discussions and no fewer than two drafts, the two new parts 1 and 2 of ISO 14644 have just been published on the ISO website. Dated 15 December 2015,… Read more »
HeX will be at the expo-colloquium organized by ASPEC
HeX will be present at the expo-colloquium organized by ASPEC January 12, 2016 handling the new standard ISO 14644.. On January 12, 2016, ASPEC is organizing a colloquium on the work done within the X44B commission of AFNOR, charged with representing France concerning the changes to the standard ISO 14644 “Cleanrooms and associated controlled environments”…. Read more »
Presentation on laminar flowsystems in operating rooms
HeX will give a presentation on “laminar flowsystems in operating rooms” at the 6th Symposium, November 14, 2015 in Namur, organized by the French Association of Nurses in Operation Rooms. Lien
An article from HeX in the SALLES PROPRES magazine
The magazine SALLES PROPRES is THE reference concerning contamination control. Its thematic report of edition n°99 of September-October 2015 discusses “the control and monitoring of environments”. HeX participated in this issue by writing an article on the “ISO 17025 accreditation: To ensure the quality if the results of tests in a clean room”. Enjoy reading…… Read more »
The ECA comments on the draft revision of Annex 1
| 5 May 2015 | The ECA Foundation reacts to the concept paper that confirmed the revision of Annex 1 of the European GMP last February. The industry and its representatives were not given much time to comment on the concept paper on the revision of Annex 1 of the European GMP: from February (when the working… Read more »
HeX & hospital pharmacies
ISO 14644-1, ISO 14644-3, ISO 14698, PIC/S 010-4, GMP HeX is the 1st testing laboratory according ISO 17025 and the first inspection body according ISO 17020 accredited by BELAC in the field of cleanrooms. HeX guides you with qualifications and monitoring of your installations and equipment: Preparation areas for parenteral nutrition Cytotoxic preparation areas (A… Read more »