/ Life Sciences Equipment and Consumables / Case Study

Vaccine Cleaning Validation Upgrade

The client is focused on the production and sales of peptide APIs. In order to adapt to the needs of market development, it is necessary to comply with regulatory requirements of major markets such as China and Europe/America, as well as cGMP standards. The workshop is to be renovated to added flexible isolator for protection, involving both the synthesis and purification freeze-drying area.

AUSTAR Solution

• Providing flexible isolator for isolation and protection in the synthesis area reaction kettle, centrifuge, oven, as well as weighing, dissolution filtration, sample reception, and freeze-drying areas. • Providing reactor, centrifuge platform transformation and air pipe site transformation construction services and validation services.

Highlights

Flexible isolators use single-use barrier technology to prevent cross-contamination.

No cleaning validation required when changing products, improving efficiency.

Compliant with cGMP requirements in China, Europe, and the US.

AUSTAR Value & Client Benefits

• Flexible isolator uses single-use barrier technology to prevent exposure to highly toxic and active substances, protecting the environment and personnel safety. • Only the film material needs to be replaced, without cleaning validation, avoiding cross-contamination. Improved production efficiency, in compliance with GMP requirements in Europe, America, and China.
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