Solutions for the Complex Challenges of Pharmaceutical Manufacturing

Pharmaceutical manufacturing requires highly specialized skills, automation experience, and the world’s best quality-control, validation, and verification processes. The pharmaceutical industry demands strict adherence to safety and quality manufacturing protocols, and is one of the most challenging and complex manufacturing environments in the world today.

Quality manufacturing of your products is essential to building and maintaining brand quality and image. Any failure to comply with regulations can lead to potentially disastrous results for a company and dangerous effects on customers. It’s been said that an ounce of prevention is worth a pound of cure. At Clarke Solutions, we regularly see the truth of this with our pharmaceutical partners.

We deliver solutions that consistently improve operations and quality for your manufacturing needs. Our solutions include the design, installation, testing and maintenance of key manufacturing processes, including:

Combination Drug-Device Manufacturing: This area is one of our fastest growing areas of expertise. More and more drug/device combination products are being launched each year. Combination products or devices are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. These products are regulated by the FDA and pose challenging regulatory, policy, and manufacturing challenges. Clarke has a group of engineers focused solely in this area as it typically covers molding of parts, drug product itself and the custom automation needed to put them all together. We rely heavily on our design for manufacturability experience to deliver equipment suitable to meet FDA guidelines and operate effectively in a GMP environment.

Aseptic processing and filling: Aseptic Filling starts long before the filling of containers, as our well-seasoned Engineers are aware. This is the process in which a sterile (aseptic) product—typically food or pharmaceutical—is manufactured and packaged in a container in a way that maintains sterility. Aseptic processing makes worldwide export and import of new, economical, and safe food and pharmaceutical products possible. Some of our equipment experience consists of:

  • Ancillary equipment such as Steam Sterilizers, Parts Washers, Closure Processors, Vaporized Hydrogen Peroxide (VHP) Chambers and Lyophilizers.
  • Continuous and batch filling operations from Batch container washers, depyrogenation ovens, and table top fillers to fully automated lines with container overwrapper removal, washing, depyrogenation, filling, full and partial stoppering, tray loading for lyophilization and capping.
  • Additionally, our engineers work with our clients to determine if Restricted Access Barrier Systems (RABS) or Isolator technology is the right choice for the application.

Full start up, commissioning, qualification and performance validation can be provided by our well rounded engineering and validation staff for all the processing and filling equipment.

Oral Solid Dose Manufacturing/Dry Products – Clarke Solutions’ experts support each step in the manufacturing process, including product granulation, drying, blending, tablet compression, and coating. This includes the ancillary systems such as solution preparation and delivery, processing equipment, and Clean In Place (CIP/SIP) systems

Continuous Process Manufacturing: Continuous production is a flow production method used to manufacture, produce, or process materials without interruption. Continuous production is called a continuous process or a continuous flow process because the materials, either dry bulk or fluids that are being processed, are continuously in motion, undergoing chemical reactions or subject to mechanical or heat treatment. Continuous processing is contrasted with batch production.

For more information regarding Pharmaceutical Manufacturing, contact us here or call 317.849.0330 today for a free, no-obligation risk assessment.