Engineered Systems - September 2008 - (Page 72)

One steam is clean. Another steam is chemical-free. Are they interchangeable? And what effects do pharmaceutical manufacturing best practices and regulations have on the usual humidification specification process? Let this brief but specific article be your prescription for wiser design. BY MARK A. BUTLER AND SAMUEL R. COLUCCI, P.E. H VAC systems play an important role in the manufacturing of pharmaceutical products. Operator comfort, temperature, humidity control, directional airflow, cleanliness classifications, contamination control, and process control are several ways that HVAC systems can impact the manufacture of pharmaceutical drug products. The purpose of this article is to add to the current body of knowledge on humidification by raising awareness of the regulatory considerations and requirements design engineers should be aware of and to discuss the types of steam used in pharmaceutical facilities. The topic of IAQ and humidification using direct steam injection is a popular one. In fact, new technologies and new more environmentally friendly chemicals and methods have been developed and continue to be developed that address health concerns and our current technology. To begin the discussion, it is important for the design engineer to understand the type of process application, regulatory requirements, and the terminology used to describe various steam systems in use in the pharmaceutical industry. In general, steam used in pharmaceutical facilities can be separated into three categories clean steam, chemical-free steam, and plant / utility steam. Intended use of steam Method of steam generation Parenteral and non-parenteral dosage form The use of a clean steam generator (CSG) applications where steam is in direct con- with entrainment for the control of endotoxtact with the drug. ins and liquid carry-over CSG is both baseline and common industry practice. Critical step in manufacture of active phar- The use of a CSG is both baseline and commaceutical ingredient (API) where steam is mon industry practice. in direct contact with the API. Non-critical step in manufacture of an API CSGs are commonly used; however, utility where added impurities may be removed in steam is the acceptable baseline application. a subsequent step. Sterilization of USP water systems. While the use of a CSG is common practice, an alternate approach is to use utility steam plus hot USP water, flushing, and waste testing. Humidification of non-critical HVAC systems Utility steam may be totally acceptable. such as room and areas where the drug is not directly exposed to the room atmosphere. Humidification of process and critical clean- Where open processing takes place and where rooms the potential level of amines, hydrazine’s etc. in the condensate has been determined to have a detrimental effect in the product the baseline and common practice is the use of CSG. However, if it has been determined that the impurities have an insignificant effect on the drug product, a utility steam source would qualify as the baseline approach. Energy source for non-critical and cGMP The baseline approach would be to use heat exchanges. plant steam source. TABLE 1. Good manufacturing parameters used to determine method of steam generation for typical applications. 72 En gi neer ed Sy stem s September 2008

Table of Contents Feed for the Digital Edition of Engineered Systems - September 2008

Engineered Systems - September 2008 Contents Editor's Note HVAC Challenge Back2Basics Case In Point Commissioning Building Automation HVACR Designer Tips Application Checklist LEED®, Or Get (It) Out Of The Way? BACnet Supplement Race To Market Steam Humidification In Pharmaceutical Facilities Outside Air, Inside Data Centers Forecast: Increasingly Cloudy And Under Control Products Computers & Software Literature Glossary Classifieds Advertiser Index Tomorrow's Environment

Engineered Systems - September 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.