How do I determine the suitable specification for water for use in generation of clean steam?

In contrast to process water, there is no pharmacopoeia standard for water for clean steam purposes (or any type of steam for use in pharmaceutical manufacturing). A specification for the purity of such steam must be prepared by each manufacturer, and the specification must be such that they meet the GMP requirement to avoid contamination […]

There are different methods for producing water for WFI, how do I determine what is the most suitable and economical method for use in my facility?

This is not a simple answer. The method of choice is dependent on whether the WFI is used as final rinse water, or is actually used in the production process. The specified water quality has to be achieved, not only at the output of the water treatment plant, but also at the points of usage, […]

How do I determine whether a single tank or multi-tank CIP system is suitable for my facility?

This is not a simple answer and does need some clarification as to the type of industry the CIP system is to be designed. There are single and multi-tanks systems that are for single use CIP, and there are multi-tank systems that are for re-use of the CIP solutions. For the multi-tank re-use CIP systems […]

I’m thinking of purchasing a CIP unit for use in cleaning my bioreactors. How do I determine whether the CIP system unit is suitable to meet my cleaning needs?

A proper assessment needs to be performed on your equipment to assure that variables of temperature, velocity/pressure, chemical concentration, and exposure time are precisely delivered to all areas effectively for your equipment. (It should be noted that some older style bioreactors may not be suitable for cleaning, and manual cleaning may be the best option.) […]

Is there a recommended sanitization/maintenance program for a distribution system for process air piping?

The use of properly rated terminal filters (with verified integrity/particulate removal efficiency) is sufficient to secure no risk of undue product contamination, along with suitable sanitary piping downstream of the filter. Most sanitization/maintenance programs would focus mainly on the terminal filter and piping downstream from the filter. Upstream, you would need to ensure that air […]

Are there guidelines for use of threaded and compression fittings vs. welded connections for use in piping for process gases?

This would depend on your application and gas type being used. For pure air systems, threaded and compression fittings could be used upstream from the terminal filters, but for other purified gases, and for piping and connections downstream of the terminal filters, I would recommend use of welded fittings. You should also ensure the piping […]