Pharmaceutical technology

Crystals of high quality

The capacity to obtain high quality active ingredients in the crystalline form is crucial to ensure the technological and performance profile of the finished medicinal product. We discussed with the experts the main features of a good crystallisation process

Risk assessment becomes more stringent

The new EU guideline 2015/C 95/02 calls pharma companies to run by March 2016 a detailed analysis of the impact and risks expected by the use of the excipients in product development and manufacturing. We discussed the key points of the guideline with representatives of both the suppliers and the pharmaceutical industry
Clean room validation

A safe environment for safe drugs

The clear room validation is a critical point in the global validation of the production process for sterile drugs. Many factors should be considered, together with accurate risk analysis and process planning. Future might see different approaches to clean room validation
HPAPI containment

Trends in risk containment

High potency active pharmaceutical ingredients are often highly toxic and need special layouts for production equipment in order to ensure worker’s security. Containment measures have reached maturity and can be personalised according to company’s needs