PHARMA-SD® 制药级喷雾干燥机从适用于在 cGMP 条件下进行测试和小规模生产的实验设备，一直可以扩大到具有 4,000 公斤/小时标称干燥气体速率的大规模生产装置。 GEA 还能提供具有高度密闭设计的 PHARMA-SD® 喷雾干燥机，可在满足OEL值低于 10 微克/立方米的情况下对高活性复合物进行安全的喷雾干燥。 这种设计在设备运行、收料和清洗期间能对人员进行有效的保护，从而营造安全的工作环境。 这使得制药公司能够充分利用喷雾干燥的优势，即使是面对高活性产 …

Our PHARMA-SD® range comprises a complete portfolio of GMP spray drying plants – ranging from the PSD-1 lab size units suitable for initial testing under GMP conditions and small productions – to the largest GMP production units for industrial purposes.

In small spray drying plants like PHARMA-SD® type PSD-1 and PSD-2 ducts and main components are joined by clamp connections, making dismounting and manual cleaning easy.

GEA PSD 2 – aqueous and organic solvent capable (≤ 70kg batches) --> Agitated vacuum dryer for secondary drying of spray dried powder. GEA PSD 4 – aqueous only – plans available for upgrade to solvent capability (80 – 500kg batches). GEA …

The PSD offers a choice of three atomizer systems: rotary, co-current two-fluid nozzle, and fountain two-fluid nozzle. It dries both aqueous and solvent feedstocks safely.

Esteve Química offers spray drying capability at the Celrà manufacturing site to complement API synthesis. Celrà offers both R&D and industrial cGMP scale spray drying capacity: • Laboratory scale Spray Dryer (Büchi B290) Typical batch size: 2 to 500g • PSD-1 Spray Dryer (GEA Niro)

2012年3月26日 · The GMP facility of the plant is equipped with two PHARMASD spray dryers, type PSD-1 and PSD-4, to produce the required quantity of samples. The PSD-1 spray dryer can be used for production in small quantities and PSD-4 for large scale production.

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Droplet size and resulting SDD particle size for an example HPMCAS spray solution is shown for GEA Niro PSD-1 and PSD-2 spray dryers. The droplet-size correlations can also be linked with correlations of droplet size to particle size and used to evaluate the criticality (and sensitivity) of spray-solution and nozzle operating parameters.

Guidelines and regulations given by US Food and Drug Administration (FDA), EUDRALEX (EU) or International Conference on Harmonization (ICH). Drying chamber and bag filter of standard PHARMA-SD® type PSD-2 spray dryer. Powder collection in clean room, custom-designed PHARMA-SD® type PSD-4 at GEA Spray Drying Facility located in Soeborg, Denmark