Powder Handling
Done With the Highest Precision
We produce our powder products with a fully-documented and audit-trailed quality system to support you in every stage of your process. Each production aligns with ISO 13485 and GMP guidelines.
Advantages at a Glance
- Full documentation from raw material to final product
- MES controlled production process for error exclusion
- Defined and homogenous milling and blending
- Excellent solubility of the powdered media
Raw Material Qualification
- We only incorporate cell culture approved raw materials
- Each supplier is qualified through our QMS
- Only highly regulated chemicals are used (EP/USP)
- We perform an intensive incoming control of each component
Manufacturing Process
Weighing: We only incorporate cell culture approved raw materials from qualified suppliers. Our staff, raw materials, production protocols, and equipment are harmonized by a GMP-compliant, computer controlled MES.
Milling: We utilize a state-of-the-art pin mill and air classifier technology. The high air flow rates feature temperature-controlled grinding to minimize the impact on temperature-sensitive components. The final product's fineness is defined by precise particle size and distribution.
Blending: Our stainless steel conical blenders guarantee a consistent blending process from small-scale up to large batch sizes. The result is a high-quality, free-flowing, easy-to-dissolve, and fully homogenized powder. The entire environment is air-classified and controlled by the latest technology.
From raw material selection to the finished product, the entire process adheres 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 procedure that incorporates intermediate milling and blending steps, followed by qualified, cell culture-grade water to ensure thorough cleaning between batch productions.
Our Promise
- Animal component-free manufacturing
- Fast turnaround times: 4 to 6 weeks until delivery
- Flexible range of powder production capacities
- Lot-to-lot consistency in homogeneous productions
- Large-scale powder batches for up to 30,000 L liquid product
- Production of customized formulations with tailored packaging, starting from 2 kg batch sizes
The Process: From Raw Materials to Final Product
Raw Materials
Our raw materials are sourced from qualified and audited suppliers. For all critical chemicals, we implement a dual-supplier strategy to secure the supply chain. Each raw material undergoes rigorous incoming quality control to verify and certify the product. It is analyzed by Raman spectroscopy to ensure traceability and trackable identity control.
Each chemical is selected based on specific parameters, such as cell culture suitability, endotoxin levels, and EP and USP standards (where available). All components are certified as "animal component-free".
Weighing System
To reduce the risk of human errors, we have implemented a validated, periphery-independent, and GMP-compliant Manufacturing Execution System (MES) in our production process, including our Fast-Track production site. The system is connected with every scale and guides our technical staff through each procedure.
Milling
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, both attributes 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 – Every aspect of the process is designed for customer handling and scalable manufacturing. Therefore, our powder simplifies solubility, maximizes performance, and is available in every phase of your process.
Blending
Our powdered cell culture media production is divided into pre-mixing and post-mixing phases. Only this combination guarantees a gentle, uniform, and repeatable mixing process. This high level of thoroughness eliminates the risk of product distortion. To ensure sterility, the blenders undergo regular sanitation procedures using qualified, cell culture-grade water.
Packaging and Logistics
Flexible packaging options and secured delivery are integral to our quality philosophy, ensuring the highest levels of safety and compliance. We provide a wide variety 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.
Customized Powder & Formulation
Capricorn Scientific offers a range of media, feeds, and buffer solutions in powder format, suitable for both small-scale and large-scale production. From pilot scale to full production quantities, the same validated milling and blending technology can be utilized, ensuring enhanced efficiency and flexibility in the scale-up process.
In addition to standard quality control, additional tests such as HPLC analysis and stability studies are carried out upon request. We also provide customized media production of special formulations, along with flexible packaging and delivery options, as part of our comprehensive service.
