Author Archives: Tim Sandle

Expanding Considerations in Cleaning Validation: Risks Posed By Indirect Product-Contact Surfaces on Pharmaceutical Equipment

Cleaning validation receives a great deal of attention within the biopharmaceutical industry, not least because of the risks of product adulteration and hence patient harm from improperly cleaned surfaces (notwithstanding additional concerns such as operator protection). Traditionally, cleaning validation efforts focus on direct product-contact surfaces. However, the hazard and resultant risk posed from indirect product-contact surfaces should not be underestimated. Consideration of the risks presented by indirect surfaces should figure into every contamination-control strategy. Understanding of these risks cannot be…

eBook: BPI Lab — Contemporary Approaches to Data and Organization

Laboratories provide essential support functions in biopharmaceutical development: from cell-line development through process validation, environmental monitoring, and preclinical analyses . . . to product characterization, formulation, and stability testing. Regulatory compliance is important across the gamut of such laboratory work. Modern companies are implementing lean concepts that facilitate organization and workflows in laboratory operations. And companies around the world can use the latest technology to ensure data integrity for their analytical results. Included herein are two articles that originally appeared…

Risk Considerations for Aging Pharmaceutical Facility Cleanrooms

Pharmaceutical facility cleanrooms are designed to reduce and control particle contamination and to minimize the ingress and retention of microorganisms. Such risks typically are easy to control in well-designed, modern facilities. But risk mitigation is more difficult in older facilities. There is no exact definition of what constitutes an aging facility (or what are sometimes euphemistically called legacy facilities). For example, a facility established 100 years ago to manufacture a simple tablet can continue to operate perfectly well with careful…