A medical device's package plays a key role in safely delivering treatment to patients. It must ensure the integrity of the device from the point of manufacture to the point of final use. In addition, ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...

Applying DOE and Risk-Assessment Methods Early Eases Process Validation However innovative or compelling a novel manufacturing process may be, its value depends on the ability to validate the process ...

Quality and reliability are essential in pharmaceutical manufacturing. To ensure compliance and high standards are consistently met, the Installation Qualification (IQ), Operational Qualification (OQ) ...