Pharmaceutical Aseptic Fill-Finish & Sterilization
With 25 years of Fill-Finish experience, Pii's experts are uniquely qualified to take on complex formulations. Our cGMP Certified facilities are integrated with our analytical, quality assurance, and fill-finish teams. Whether you are starting a clinical trial, ready to scale up, or looking to perform a Tech Transfer - our team is ready to help produce the results that you and patients need.
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Flexible Small & Medium Batch
Pii has over 25 years of experience managing the development of parenteral formulations for Clinical Trials and implementing scale up/ Tech Transfer. Our four sterile fill-finish suites use single use technology in strict accordance with cGMP requirements.
Our core aseptic/sterile fill-finish capabilities are ideal for clinical trials, small-batch, and medium-batch commercial applications. Specifically our capabilities include:
- Delivery Systems (Batch Sizes: 1L to 1000L)
- Vial filling, closing, and sealing
- Syringe filling and closing
- Cartridge filling and closing (2ml to 100L)
- Lyophilizer Integration
- Complex Projects
- Highly Viscous Solutions & Suspensions
- Highly-Sensitive Formulations
- Small to Large Molecule
- Aqueous, nonaqueous and highly viscous
- Inclusion complexes
- Dispersed Systems
- Suspensions (aqueous and nonaqueous)
- Polymeric particles
- Lyophilized Powders
Quality Aseptic & Sterile Production
Our proven and experienced team of scientists, engineers and regulatory affairs professionals serves you through the entire development process. As a partner, our team ensures that we will remain transparent & responsive to your development needs. Pii's team ensures the product quality & safety - making sure that the proper results are delivered to the patient. During the drug development process, some security measures include:
- Employing Single Use Technology
- Using Non-Destructive Testing Procedures
- Cross-Contamination Prevention
Each of Pii's facilities follow strict accordance of cGMP requirements and utilizing QbD principles.
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25 Years of Aseptic Fill-Finish Project Management
With 25 years of experience, Pii knows how to develop or scale up your fill-finish needs. This experience allows us to achieve the necessary results throughout the complex production process. Our client-oriented philosophy allows for precise production, agility, and integration. Our capabilities assist us for orphan drug programs, initial clinical trial batches, and challenging drug projects that require flexibility & agile response times.
Our project management team develops a phase-appropriate scope aligned with patient's needs and client's resources. By vertically integrating our facilities, quality assurance team, regulatory support, analytical services, and fill-finish experts - we are able to improve the quality and speed of your product.
Pii customizes each project to the needs of the clients. Pii does not try to fit their clients’ projects into a proprietary technology owned by Pii. All work done by Pii on behalf of a client and their project is owned by the client.
Robotic Aseptic Fill-Finish: A Game-Changing Flexible Solution
The GENiSYS® R filling line provides reliable and flexible processing, minimizes manual operations, and reduces product waste, common at the beginning and end of batch manufacturing.
Eliminating waste is key to successful small-batch processing. Necessary operations such as pump calibration, in-process fill weight checks and residual product hold-up in the fluid path all contribute to product rejects. The GENiSYS® R’s in-process control system allows for 100% fill weight inspection with minimal reduction in processing speeds to minimize or even eliminate improperly filled containers and minimize product hold-up at the end of the batch – resulting in maximum product yield. In addition, the Electronic Batch Record (EBR) system provides a complete record of the dispensed material.
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Integrated Lyophilization for Aseptic Fill-Finish Production
Developing an effective lyophilization cycle is both art and science. Our skilled, experienced team of professionals, using Millrock lyophilization technology, provide critical synergies between the development lab and manufacturing line, ensuring your outcomes are met with the highest quality and always on time.
In order to provide the best possible transfer between the development-scale process and the production-scale process, we utilize Millrock lyophilization technology in the lab and in the production unit. This allows for the synergy of technology and engineering factors critical for scale-up and transfer activities.
CAPACITY: Our development-scale lyophilizer has a chamber suitable to produce a range of different batch sizes for evaluation of process parameters or producing supplies for various studies. These studies include but aren’t limited to the development of analytical methods, production of reference standards, non-pivotal toxicological supplies, and evaluation of stability.