Food Grade Oils Used in the Pharmaceutical Industry for Punch & Die Lubrication
Introduction
In pharmaceutical tablet manufacturing, punches and dies undergo continuous mechanical stress and friction during compression. To ensure smooth operation, prevent wear and tear, and extend tooling life, lubrication of punches and dies is essential. However, since the process involves direct contact with medicines, only food-grade oils and lubricants that comply with regulatory standards are permitted. These oils must be non-toxic, odorless, colorless, and free from harmful contaminants.
Why Use Food-Grade Oils for Punch & Die Lubrication?
Regulatory Compliance – Meets GMP, FDA, and USP standards.
Safety – Non-toxic and safe even if trace amounts come in contact with the product.
Equipment Protection – Reduces friction and wear, increasing punch & die life.
Corrosion Resistance – Protects steel surfaces from rust and oxidation.
Improved Efficiency – Ensures smooth tablet ejection, reducing downtime and sticking.
Common Food-Grade Oils Used in Pharma
1. White Mineral Oil (Light Liquid Paraffin, Pharma Grade)
Widely used for punch & die lubrication.
Highly refined, colorless, odorless, and tasteless.
Provides excellent lubrication and corrosion resistance.
Complies with pharmacopeia standards (IP, BP, USP).
2. Food-Grade Synthetic Oils
Designed specifically for pharmaceutical machinery.
Stable at high operating temperatures.
Do not leave sticky residues.
Examples: PAO (Polyalphaolefin)-based synthetic lubricants approved for incidental food contact.
3. Vegetable-Based Oils (Food Grade)
Derived from natural plant oils such as sunflower or canola oil.
Biodegradable and environmentally friendly.
Used where minimal contamination risk is required.
4. Specialty Food-Grade Lubricants (NSF H1 Certified)
Oils and greases certified for incidental food contact.
Contain additives for high-load protection and anti-wear properties.
Examples: Food-grade ester oils, semi-synthetic blends.
Best Practices for Punch & Die Lubrication in Pharma
1. Use Minimum Quantity – Excess oil can contaminate tablets. Apply as a thin film.
2. Regular Cleaning – Clean punches and dies before lubrication to avoid residue build-up.
3. Approved Oils Only – Use only pharmacopeia-grade or NSF H1 certified oils.
4. Scheduled Maintenance – Apply lubrication at defined intervals during production.
5. Avoid Cross-Contamination – Store lubricants separately and label clearly.
Regulatory Standards
US FDA 21 CFR 178.3570 – Lists lubricants allowed for incidental food contact.
NSF H1 / H3 Certification – Recognized global standards for food-grade lubricants.
Pharmacopeial Compliance (USP, IP, BP) – Ensures purity and safety.
Conclusion
Lubrication of punches and dies with food-grade oils is a critical requirement in the pharmaceutical industry to maintain smooth operations, extend tooling life, and ensure patient safety. White mineral oil remains the most common choice, but synthetic and specialty food-grade lubricants are increasingly being adopted due to their superior performance and regulatory approvals. By following GMP guidelines and using only certified lubricants, pharmaceutical manufacturers can achieve safe, efficient, and contamination-free tablet production.