Powder Handling

Done with highest precision

We produce our powder products in a fast-track program or in fully documented ISO 13485 certified quality system to support you in every stage of your process.

 

Advantages at a glance

  • Full documentation from raw material to final product
  • Defined and homogenous milling and blending
  • Excellent solubility of the powder media
  • Extended final product analysis upon request

Powder manufacturing

We have established a joint venture with our partner for the manufacture of powder media for our biopharmaceutical customers. The powder plant was established in 2020 with the latest technologies in both milling and blending thus providing our customers with full homogeneity of powder media from 0.7 up to 2000 kg batch sizes.

Manufacturing process

We utilize a state-of-the-art cooled pin mill and air classifier. The high air flow rates feature temperature-controlled grinding to minimize the impact on temperature-sensitive components. The end product fineness is defined by the air classifier and dependent on the particle size. The cut off particle size is precisely defined for excellent media solubility. Several different dimensioned conical blenders guarantee a consistent blending process from small scale up to large volume batch sizes. The result is a high quality, free-flowing, easy to dissolve, and fully homogenized powder. The whole environment is air class controlled by the newest technology.

Our two product lines, the fast-track program or a fully documented ISO 13485 quality program, are produced in two separate production environments.

From raw material selection to the finished product, the whole process conforms to the EU-GMP guidelines. This saves valuable time for our customers and facilitates the regulatory submission process for biopharmaceutical production.

The cleaning of the system is done by a validated WIP system using WFI water to ensure proper cleaning between batch productions.

Our promises

  • Fast turnaround times: 6 to 8 weeks until delivery
  • Flexible range of powder production capacity
  • Lot-to-lot consistency
  • Scalability design control from small to large batches
  • Animal component-free manufacturing
  • Large scale powder batches available (e.g. 2000+ kg)
  • Customized formulas and packaging configurations available upon request

The process from raw material to end product

Raw material

Our raw materials are sourced from qualified and audited suppliers. For all important chemicals, we run a double-supplier strategy to secure the supply chain. Each raw material goes through detailed incoming quality control to verify and certify the product. It is analyzed by Raman spectroscopy to ensure trace- and trackable identity control.

Each chemical is chosen by specific parameters such as cell culture suitability, endotoxin values, and EP and USP standards (where available). All components are certified free of animal components.

In order to reduce the risk of human errors we have included a validated, periphery-independent and GMP-compliant Manufacturing Execution System (MES) in our GMP production process as well as in our Fast-Track production site. The system is connected to every scale and leads our technician staff through each procedure.

The central features of our state-of-the-art cell culture pin mill are consistency, fineness, and efficiency. These parameters lead the way in our powder cell culture media production.

Consistency – Particle size and distribution are optimized and rigorously controlled. Together they lead to consistent results.

Fineness – A full-blown closed-loop inert system ensures a clean environment. The milling process is temperature controlled to prevent heat damage to the chemical constituents.

Efficiency – Each part of the process is dedicated to customer handling and scalable manufacturing. Therefore, our powder simplifies solubility, maximizes performance and is available in every phase of your process.

Our powder cell culture media production is divided into pre- and post-mixing. Only this combination guarantees a gentle, uniform and repeatable mixing process. This high level of thoroughness removes the risk of product distortion. To ensure sterility these blenders are routinely subjected to a WIP-sanitary procedure using WFI-water.

The possibility of flexible packaging and secured delivery is part of our quality philosophy. Our approach serves the highest levels of safety and compliance. We provide a range of qualified primary and secondary packaging along with a range of additional shipping and storage options including "Temperature-controlled freight", "Temperature monitoring", and "Tracking with just-in-time delivery".

Capricorn Scientific offers a range of basal media and buffer solutions from small scale to large scale in powder format. From pilot scale into full production quantities the same validated milling and blending technology can be utilized. This results in enhanced efficiency and flexibility for the scale-­up process.

In addition to standard quality control, additional tests such as HPLC analysis and stability studies are carried out upon request. The customized media production of special formulations with flexible packaging and delivery options is also part of our service.