Manufacturing
Our state-of-the-art powder blending, encapsulation, tablet compression, and on-site laboratory testing services adhere to the highest standards in the pharmaceutical and nutraceutical industries.
With our cGMP-compliant facilities and gold-standard technology, backed by our skilled team, we’re known for meeting our customers’ needs with the highest quality.
We know that blending of active pharmaceutical ingredients (APIs) and excipients to create a homogenous blend is critical in the manufacturing of solid and powder dose pharmaceuticals. To ensure correct blending speed and time, we are equipped with:
- One 100 pi/cu ribbon blender
- Two bin blenders (up to 940 L and up to 2,000 L)
At Ropack, we pride ourselves on the flexibility and agility of our manufacturing capabilities. Validated processes bring the quality and reliability we’re known for to our encapsulation services. We offer:
- Two encapsulation machines
- 40,000 capsules/hour
- 60,000 capsules/hour
- Total capacity: 305 million/year
- Capsule size range: 3 to 00
- Low relative humidity (RH) and temperature control for maximum product protection
- Class 100,000 production environment, inspected by the FDA and Health Canada
- Over-encapsulation
To complement our manufacturing capabilities, Ropack offers direct compression of tablets using a multi-station rotary tablet press in conjunction with our blending capabilities or using customer-supplied powders.
Various sizes and shapes of tablets can be customized to perform product transfer, scale-up, validation, and commercial batches to meet market needs.
Our analytical laboratory is integrated with our manufacturing and packaging operations and is capable of providing reliable chemical and microbiological testing in compliance with cGMP requirements. To help get a compliant product to market quickly, we offer:
- Testing of raw materials, packaging components, and finished products, including microbial identification
- Method verification, validation, and transfer of analytical methods
Check out Ropack’s internal laboratory for chemical and microbial analysis
Strategic scale-up and tech transfer support that follows scale-up and post-approval changes (SUPAC) guidelines
- We offer a complete process validation in accordance with regulatory and cGMP guidelines, enabling you to establish a reliable, high-quality commercial supply.
- Ropack provides you with reliable points of contact with project and process transfer managers dedicated to your specific needs.
- A cross-functional team of skilled pharmaceutical professionals ensures you a compliant, successful product launch.