By Andrea Wagner, Ph.D. SVP, Business Development, Berkshire Sterile In a recent training at Berkshire Sterile, the topic of risk assessment was covered. This topic is a very important one with FDA and others, such as clients, around the country. In this training I learned about how Berkshire Sterile assesses risk in relation to cGMP… continue reading
These are pre-nested, pre-siliconized, stoppered, crimped and nested then sterilized. This allows easy filling on a syringe filling line (with a small retro-fit) and allows companies to easily evaluate using cartridges without a dedicated line. continue reading
Andrea Wagner, PhD, SVP, Business Development, BSM Less than 10 years ago you needed different filling equipment for vials, syringes and cartridges. The ability to buy and install isolators for each of these separate operations in a CMO was cost prohibitive. Companies that had high volume production of one product with one type of container… continue reading
By Andrea Wagner, PhD, SVP Business Development Recently Phil Burns wrote an article in Contract Pharma about utilizing contract manufacturing organizations (CMOs) to assist companies to reduce their stress in production requirements.   He stated that CMOs can help companies with immediate and distant manufacturing needs but they need to consider several areas prior to choosing… continue reading