Reliable supply is a key factor in the selection of potential suppliers for the pharmaceutical industry. Quality is another criteria – especially when it comes to products with special properties, such as high-purity solvents. The expectations on the producer are high: continuous availability, ensuring relevant product properties and consistent quality. In this blog article we will outline which aspects are important when sourcing solvents for the pharmaceutical industry.
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The most important requirements for solvents for the pharmaceutical industry
The production of active ingredients (AI) in the pharmaceutical industry is an area with special requirements. In comparison to others, the industry is not subject to strong fluctuations, as the demand for drugs is constantly high and immediate security of supply must be guaranteed. The ability to supply base products, such as solvents, is one of the most critical requirements. Suppliers of solvents should be able to ensure continuity of production and supply.
A supplier should be able to offer:
- Worldwide distribution
- Digital logistics modules such as Track & Trace systems
- Flexible solutions for filling, packaging and logistics
High quality standards in the production of active pharmaceutical ingredients
Another essential parameter in the production of active pharmaceutical ingredients (APIs) is consistent quality, as production requires a very high degree of purity. Solvents play an important role in the production process of active pharmaceutical ingredients (APIs) and must meet the highest standards.
The solvents are used in research and development laboratories for classical analyses and syntheses, and are also necessary in the production process for workup, crystallization, washing of purified substances and extraction. High-performance hydrocarbon products are required to have a purity of up to 99.75 % and meet the highest requirements of the industry. The high purity in particular allows efficient and targeted control in synthesis steps. This is of fundamental importance to the pharmaceutical sector.
Impurities can severely disrupt the manufacturing process and, in the worst case, lead to plant downtime and production losses. This can be avoided with high-purity products such as paraffins of the best quality, with low water content and low evaporation residue. Trustworthy producers of solvents can ensure consistent quality in their own laboratories, which are accredited according to ISO/IEC.
Click here to read the expert interview: How labs test the quality of high-purity paraffinic hydrocarbons
Highest reliability through customised solutions
A further benefit is the range of application-specific solvents. The possibility of obtaining individually tailored specifications and mixtures shows a strong customer orientation of the manufacturer. For customers, this means the highest reliability and proven safety for their analysis requirements and production processes in both complex and individual applications.
Conclusion
Qualified manufacturers of specialty chemicals, in particular high-purity hydrocarbons, must meet the high standards of the pharmaceutical industry and at the same time fulfill individual product and supply chain requirements. In the best case, they are strong partners with many years of expertise in application-oriented solvents. Check if your supplier offers the following services:
- Supply capability through an independent supplier network
- Flexibility
- Rapid implementation of customer requirements
- Production safety
- Quality assurance
- Certifications
- Consistent high quality
Find out what benefits Haltermann Carless high-purity solvents can offer to the pharmaceutical industry.
What Are Industrial Solvents?
Industrial solvents are substances, typically liquids, that have the ability to dissolve, suspend, or extract other materials without chemically changing either the solvents or the other materials. They are crucial in a myriad of industrial processes, including cleaning, degreasing, chemical synthesis, and as carriers in formulations such as paints, adhesives, and inks.
The unique properties of solvents, such as their boiling point, evaporation rate, polarity, and toxicity, make them suitable for specific applications. Understanding these properties is essential for selecting the right solvent for a particular task.
Types of Industrial Solvents
Solvents are generally classified based on their chemical structure and polarity. The main categories include:
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Hydrocarbon Solvents: Derived from petroleum, these include aliphatic solvents like hexane and aromatic solvents like toluene.
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Oxygenated Solvents: Contain oxygen molecules; examples include alcohols (ethanol, isopropanol), ketones (acetone, methyl ethyl ketone), esters (ethyl acetate), and glycol ethers.
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Chlorinated Solvents: Contain chlorine atoms; examples are perchloroethylene and trichloroethylene.
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Others: Including specialty solvents like D-Limonene, derived from citrus oils, and bio-based solvents.
Common Applications of Solvents
Solvents are integral to various industries due to their ability to dissolve, dilute, and carry other substances. Here are some common applications:
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1. Cleaning and Degreasing
Solvents like acetone and isopropanol are excellent at dissolving oils, greases, and other contaminants, making them essential for cleaning machinery, electronic components, and surfaces.
2. Paints and Coatings
Solvents act as carriers in paints and coatings, enabling the application of pigments and resins. They evaporate after application, leaving behind a uniform film.
3. Chemical Synthesis
Many chemical reactions require solvents as a medium to facilitate the interaction of reactants. Solvents like toluene and methanol are commonly used in synthesis processes.
4. Pharmaceuticals
Solvents are used in the formulation of medications, extraction of active ingredients, and cleaning of equipment.
5. Adhesives and Sealants
They help in adjusting viscosity and improving the application properties of adhesives and sealants.
6. Extraction Processes
Solvents like hexane are used in extracting oils and other compounds from natural materials, such as in the production of vegetable oils.
Safety Considerations
By following these safety measures, you can minimize risks associated with solvent handling and protect both personnel and the environment.
Choosing the Right Solvent
Selecting the appropriate solvent for your application involves considering several factors:
1. Solvent Properties
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Polarity: Polar solvents (e.g., water, ethanol) dissolve polar substances, while non-polar solvents (e.g., hexane) dissolve non-polar substances.
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Boiling Point: Determines the evaporation rate; critical in applications like coatings where drying time is important.
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Toxicity: Less toxic solvents are preferred for health and environmental reasons.
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Flammability: Non-flammable solvents may be required in certain environments.
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Solvency Power: The ability of a solvent to dissolve a particular solute.
2. Material Compatibility
Ensure the solvent does not react adversely with the materials involved, including equipment and substrates.
3. Regulatory Compliance
Be aware of regulations regarding volatile organic compounds (VOCs), air quality, and hazardous waste disposal.
4. Cost and Availability
Consider the cost-effectiveness and availability of the solvent, especially for large-scale operations.
Environmental Impact and Regulations
The use of industrial solvents has environmental implications, particularly regarding air quality and waste management. Many solvents are classified as VOCs, contributing to air pollution and smog formation.
Regulatory Framework
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Clean Air Act: Regulates emissions of hazardous air pollutants, including certain solvents.
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Resource Conservation and Recovery Act (RCRA): Governs the disposal of hazardous waste, including solvent waste.
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Occupational Safety and Health Administration (OSHA): Sets permissible exposure limits (PELs) for solvent vapors.
Best Practices for Environmental Compliance
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Use Low-VOC or VOC-Free Solvents: Opt for solvents with reduced environmental impact.
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Implement Solvent Recovery Systems: Recycle solvents to reduce waste and lower costs.
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Proper Waste Disposal: Follow regulations for hazardous waste handling and disposal.
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Spill Prevention and Control: Utilize secondary containment and regular inspections.
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Employee Training: Educate staff on environmental policies and proper solvent handling.
By integrating environmental considerations into your solvent management practices, you contribute to sustainability and regulatory compliance.
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Case Study: Solvent Selection Success
Frequently Asked Questions
Conclusion