Annex 1: Solutions in Environmental Monitoring
Environmental monitoring compliant with GMP regulations is mandatory for aseptic fill-and-finish processes under Grade A conditions. Conventional monitoring using petri dishes still results in numerous glove interventions - something that should be avoided under GMP Annex 1 wherever technically feasible alternatives exist. This article presents equipment engineering solutions that enable users to effectively reduce or eliminate glove interventions in this area.
About OPTIMA pharma
The Optima Pharma Division offers customer-specific filling and processing solutions for the pharmaceutical and biotech industries – reliable and smart. It is an expert in filling and closing, containment and freeze-drying of sophisticated pharmaceutical products and meets the requirements of its customers with a unique combination of application know-how, technological expertise as well as process and service quality. As an integrated system provider, Optima Pharma is the turnkey partner for complete lines, special solutions and sophisticated standard machines for pharmaceutical system technology. The filling line, isolator and freeze dryer come from a single source.
Optima is a technology leader in the precise dosing, filling, packaging and handling of demanding liquid and solid products. With flexible and customer-specific filling, packaging and production systems, Optima has been ensuring for more than 100 years that valuable and sensitive goods such as medicines, hygiene and medical devices, food or cosmetics reach the people worldwide who depend on these products every day. As a solution provider, the company develops and manufactures these on the basis of proven platforms. With its global service network, Optima supports its customers' systems throughout the entire life cycle and accompanies them on their way to becoming a "game changer" in the field of sustainability. The use of digital technologies ensures maximum efficiency and sophisticated solutions that make life noticeably easier for users.
More than 3,400 experts contribute to Optima's global success at its headquarters in Schwäbisch Hall and at over 20 locations in Germany and abroad. The common mission "We care for people" is in the foreground every day.
