Pii's Robotic Small Scale Aseptic Fill-Finish Production

Описание: Pii can provide you with state-of-the-art GENiSYS R aseptic filling and closure system tailored technology for pharmaceutical and biopharmaceutical The GENiSYS R aseptic filling and closure system is:

• A fully robotic, automated line
• It is Pre-qualified with no additional costs for media fill qualification
• And, customized in process controls supports real time batch records
• The GENiSYS R20 supports, multiple container options such as vials, syringes and cartridges
• Accurate precision-filling eliminates the loss of costly drug product
• Adaptable RABs offers flexibly, protecting your product and our production workers
• Continuous, non-destructive weight testing eliminate stoppages and prevents materials waste
• Rapid production line change-over, up to 2 batches per day
• The GENiSYS R20 line accommodates multiple sizes of glass components perfect for supporting small batch sizes
• Pii maintains an inventory of pre-sterilized vials and syringes on-hand to support shortened timelines

At Pharmaceutics International, Inc. (Pii), our motto is “challenges frame opportunities.” We are a contract development and manufacturing organization (CDMO) with a passion for problem-solving. Emphasizing collaboration, our experts complete projects on time with the highest quality standards, all from our Hunt Valley, Maryland campus.

Pii’s campus includes four cGMP and FDA inspected facilities, 70 manufacturing suites with all the necessary analytical testing capabilities on site, and four integrated aseptic filling suites delivering quality, safety, and efficiency. Experienced with small and large molecule compounds, we have special expertise in developing and manufacturing complex parenteral products, extended-release formulations, and non-aqueous injectable drug products. We can also overcome stability challenges with precision lyophilization cycle development and production.

From Concept to Clinical to Commercial.
Visit us at www.pharm-int.com