API Production: An Overview
APIs can be of natural origin, such as plant extracts or enzymes, or produced through chemical synthesis and biotechnological processes. During drug development, APIs are synthesized, isolated, and purified to achieve the desired pharmacological effect. APIs are often combined with inactive ingredients or excipients to formulate the final drug, which comes in various dosage forms such as tablets, capsules, or injections.
Reliable Solutions for API Production
Richter is a leading supplier of PFA-lined pumps and valves widely used in the pharmaceutical industry. These products are specifically designed for demanding applications involving aggressive chemicals and high purity requirements.
Reactors and Synthesis Processes:
Richter’s pumps and valves are used around reactors to safely handle corrosive and toxic liquids. This is particularly important in API synthesis, where corrosive chemicals are used.
Cleaning and Sterilization:
Richter products are ideally suited for Clean-in-Place (CIP) processes, essential for cleaning and sterilizing production equipment. Since these processes often involve explosive solvents an ATEX Ex-zone-compliant design is frequently required. Richter provides an option for a conductive liner that is ATEX EZ-zone compliant. This conductive lining is also available with FDA compliance.
Transport and Storage:
The transport and storage systems of raw materials and intermediates of APIs require reliable and corrosion-resistant pumps and valves. Richter products offer the necessary safety, efficiency, and durability.
Why Richter Products are the First Choice for the Pharmaceutical Industry
- Corrosion Resistance: The PFA lining of the pumps and valves is universally resistant to corrosive substances, especially the chemicals used in API production.
- Reliability and Durability: Richter products are known for their high reliability and long service life, making them ideal for use in critical pharmaceutical processes.
- Safety: The products are designed to meet the highest safety standards, which is particularly important when handling toxic and hazardous substances. The conductivity of the pumps and valves also ensures safe use in explosive areas (Ex-zones), especially when using solvents in CIP processes.
- FDA Compliance: The products meet the stringent standards of the US Food and Drug Administration (FDA) for pure and antistatic PFA. This means they can be safely used in the manufacture of pharmaceutical products intended for human consumption.
- Oil and Grease-Free Assembly: The assembly and packaging of the products are carried out according to a special cleaning specification developed in collaboration with customers from the pharmaceutical industry. This eliminates any contamination with grease and oils.
- Low Dead Space Product Design: The products are designed with minimal dead space where residues could accumulate. They are also optionally available in a completely dead space-free design, which further facilitates cleaning and minimizes the risk of contamination
- Cost Savings: Thanks to the high durability and reliability of the products, the lowest life cycle costs are incurred. Every avoided replacement of failed valves and pumps saves time and money.
- Pure PFA or Antistatic PFA: The products are available in variants made of pure PFA or antistatic PFA. Pure PFA is always FDA compliant. Antistatic PFA is FDA compliant depending on the actual material blend. Both pure and conductive PFA offer excellent chemical resistance, while antistatic PFA additionally prevents electrostatic charges on the wetted contact surfaces. This is particularly important for safety during CIP cleaning with solvents.
- Simplified and Fast Cleaning and Disassembly: The products are designed to be quickly disassembled and easily cleaned. This saves time and reduces downtime in production.
- Stainless Steel Housing: In addition to the standard design with ductile iron housings, stainless steel housings are optionally available for certain models including diaphragm valves, ball valves, and sampling valves. This offers additional advantages in cleaning the housing.
- TA Luft Certification: The products are certified according to the latest TA Luft standards of 2021 (ISO 15848). This certification confirms that the products meet the stringent German emission requirements, underscoring their environmental friendliness and safety.
Product range for pharmaceutical industry:
- Heavy Duty Ball Valves (KN, KNA): Low dead space design, maintenance-free
- Butterfly Valves (NKL, NKS): Reliable and durable
- Bellows-Sealed Control Valves (RSS): Precise control, conductive and FDA-compliant
- Safety Valves (KSE): Highest safety standards, FDA-certified
- Sight Glass Fittings (PSG): Visual monitoring, chemically resistant
- Diaphragm Valves (MV): Dead space-free, easy to clean
- Pumps (RM, MNK, SCK): High performance, PFA-lined, durable
Complete Solutions
Richter valves and pumps are also supplied as driven and automated complete units, including assembly, piping, wiring, testing, and certification of accessories.The high-performance, PFA-lined pumps and valves significantly contribute to ensuring the quality and safety of pharmaceutical production.
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