Front viewing panel is top hinged and self-supporting for easy access to the work area for cleaning and equipment ingress.HEPA filtered air shall be supplied in critical areas (ISO Class 5) at a velocity sufficient to sweep particles away from the compounding area and maintain unidirectional airflow during operations. All viewing panels are stainless steel framed Acrylic 134 Compounding Sterile Preparations the purposes of aseptic compounding, free from airborne particulate contamination.All stainless steel construction both inside and out with a pharmaceutical grade finish.Designed to fit through standard door openings and elevators.The advice of a competent professional should be sought before entering in any project. MECART hereby declines any liability for any error, damage, loss, injury or other consequence which may arise from use in any manner of any information contained in this document. Any project is different in nature and the statements provided herein shall not be deemed appropriate or relied upon for any specific application or project without subsequent analysis, evaluation, verification and assessment. However, MECART makes no representations or warranties whatsoever whether express or implied as to the accuracy, validity, correctness, currentness, completeness, suitability for any purpose of such information. MECART has made every reasonable effort to ensure the accuracy of all the information contained in this document. The views and opinions expressed herein constitute the judgment of the authors and are subject to change without notice. The information, statements, opinions and analyses provided by MECART in this document is designed to provide helpful and educational information on the subjects discussed. You can be sure your employees will be thanking you for it. For this reason, we often suggest our clients to install a humidifier in their cleanrooms. From our experience, the clean room tends to become very dry. Most regulations do not mention anything about this functional parameter, however it is important for your employees’ comfort. Another important aspect in cleanroom design and which is often forgotten is humidity.Finally, to err is human, therefore even though you have a strict operating protocol, a higher ACPH can also compensate for a human mistake. With higher air changes per hour, the air quality is less likely to be affected by the new configuration. Another common example is if you decide to make small changes to the configuration inside your cleanroom. For example, if a HEPA filter gets dirty, the cleanroom’s higher ACPH will compensate and your cleanroom will remain compliant, giving you time to replace it. This higher rate gives you time to notice a problem and fix it without having to stop operations inside the cleanroom. Even though regulations recommend 30 changes per hour for the clean room and 20 for the anteroom, we always design our cleanroom HVAC with a slightly higher air changes per hour, for example 40 ACPH (instead of 30) for the clean room and 30 ACPH (instead of 20) for the anteroom. In the following article, the focus will be on non-hazardous sterile compounding. Ontario College of Pharmacists, College of Pharmacists of British Columbia, etc.)
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |