Lubrication: the undervalued key to pharmaceutical manufacturing success

These guidelines regard contamination control as a major issue, so risk management demands that lubricants coming into contact with the product are hygienically safe; NSF H1 lubricants should be used exclusively to make manufacturing processes more reliable. This prevents the risk of lubricants being mixed up, and pharmaceutical product contamination with non-NSF H1 lubricants becomes impossible.

Full confidence in NSF H1-registered lubricants’ ability to manage chemical, physical, and biological risk comes from knowing that not only the lubricants but also their production sites are certified by NSF according to the new international ISO 21469 standards.

While facilitating GMP compliance, specialty lubricants can also increase productivity, reliability, and economic operation of machines used in the manufacturing of pharmaceuticals, cosmetics, and personal care products.

Further benefits include high resistance to ageing and oxidation, optimised wear protection,

good corrosion protection, good water resistance for protection against wash-out during sterilisation, cleaning and additional anticorrosive effects.

NSF H1-rated specialty lubricants can aid GMP compliance and improve machine performance in the cosmetics, personal care as well as pharmaceutical industries.

Pharmaceutical manufacturing examples include tablet punches in a tablet press as well as high-temperature areas in a blister packaging machine. Coaters, fluidised bed systems, capsule filling machines, granulating machines, filling machines for liquids, and peeler centrifuges can benefit from our specialty lubricants. Compressors, pneumatic drives, vacuum pumps, reactor bearings, and mechanical seals, commonly found in Active Pharmaceutical Ingredients (API) manufacturing units, also need lubricants that conform to GMP standards.

Equipment modules in the cosmetics industry include reactors (gear units for agitators, mechanical shaft seals), mixers, homogenisers, filling lines, packaging machines, air compressors, hydraulic systems, and tube transport systems. Personal care applications for specialty lubricants include reactors and high-shear mixers, aseptic valves and hygienic valves, and industrial homogenisers. Typical personal care products include creams, tooth paste, diapers and female hygiene.

In the pharmaceutical industry, applicable GMP standards stipulate that certified lubricant products, capable of passing audits, must be used. These lubricants must be H1-registered, ISO 21469-certified, and FDA-compliant to ensure that they will not contaminate the finished product.

Wear on installations and equipment should be minimised, and unplanned maintenance avoided. Other factors to be considered include the presence of multiple lube points, use of multiple lubricants, mixing, and possibly short relubrication intervals.

When manufacturing cosmetics products, DIN EN ISO 22716 (Cosmetics – Good Manufacturing Practices (GMP) provisions must be observed. Lubricants must be H1-registered, ISO 21469-certified and FDA-compliant. Additionally, personnel must be continuously GMP-trained.

Our specialty lubricants support pharmaceutical, cosmetic and personal care enterprises in meeting worldwide GMP guidelines. These lubricants will see manufacturers through any audit safely, also in terms of compliance with clean room requirements aimed at ensuring sterile production.

Relubrication intervals are extended, and unplanned maintenance is reduced, while plant availability is increased, and the service life of lubricated components is extended.

Registered lubricants from Klüber Lubrication come with extensive quality documentation, easing certification.

The right lubricant management system can significantly reduce spending on energy, labour and spare parts. A lubricant consolidation program has proven to reduce lubricant inventories by as much as 75 %. The results include a lower risk of lubricant cross-contamination, lower purchase/transport costs, and a simplification of lubricant application processes.

All information flows into an individual operational lubrication plan for you, including a description of how the respective lubrication points must be lubricated. Based on these documents, we determine approaches for optimisation such as:

• Perfectly metered lubricant quantities ensure a clean lubrication point environment
• Optimal lubricant use, for example to avoid waste and contamination
• Ideal maintenance intervals
• Ideal application methods
• Improvements to prevent downtime being required for relubrication

Our experts also draw up an optimisation plan and use it to define measures for improving your TPM (Total Productive Maintenance) processes such as maintenance, training, quality management and occupational safety, environmental protection and health protection.

No matter whether you’re involved with the manufacture of pharmaceuticals, cosmetics or personal care products, we can help you prepare the best specialty lubricant strategy for your plant. Contact us to learn more!