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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. Overview Energy recovery from HVAC exhaust is an important matter on the point of view of energy efficiency. In pharmaceutical industry, biotechnology, research labs and hospitals, 100% fresh air is very common and most times mandatory. In a 100% […]

1. INTRODUCTION For some time at public and private research centers and national and international production centers specifically designed facilities are being used for containment of dangerous biological agents in its manipulation and that could be a risk for the […]

  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 […]

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 […]