1. Introduction The requirements in the cosmetic sector are defined in the regulation of the CE Nº 1223/2009 of the European Parliament and of the Council about cosmetic products that was published in the Official Journal on December 22, 2009, […]Read more
1.Introduction The EMA has approved on the 20th of November 2014, the new guide “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”. Once approved, this guide will have to […]Read more
In pharmaceutical manufacturing plants there is always the doubt related to when it is necessary to have a dedicated facility or when it is possible to manufacture in a same area different products specially when some of them are steroids, sexual hormones, corticoids, cytostatics, high potency, prostaglandins, …
FDA and EU required dedicated facilities for betalactamics antibiotics and when manipulating pathogenic alive organisms. For the rest of products the segregation and dedicated facilities should be required when the physical and procedural controls cannot demonstrate the capacity to keep under acceptable control limits the risk of cross contamination
1. Introduction: Primary packaging suppliers are reporting investments in order to increase the use of primary materials pre-sterilized, “Ready to Use” (RU). These materials open up new possibilities and opportunities in the design of sterile manufacturing areas. 2. What’s […]Read more
In the pharmaceutical sector there is a clear tendency to develop and manufacture high potent products, currently they represent 35% of the global market share and 50% of products under development (Class 3 and 4 Safebridge classification). New areas or […]Read more
From home, office or factory, at Ingelyt we continue working for you, always complying with the safety and hygiene measures indicated in this situation of pandemic due to Coronavirus, in order to guarantee the health of our colleagues and clients and offer you the best service.
Thank you for your trust.