Pharmaceutical lubricants are substances used to reduce friction between moving parts in pharmaceutical equipment, packaging, and medical devices. These lubricants must meet stringent regulations to ensure safety and purity.
Key characteristics:
1. Non-toxicity and non-reactivity
2. Compatibility with pharmaceutical products
3. Low particle generation
4. Resistance to corrosion
Common types:
1. Silicone-based lubricants
2. Water-soluble lubricants
3. Synthetic lubricants (e.g., polyethylene glycol)
4. Mineral oil-based lubricants
Applications:
1. Tablet presses and coating equipment
2. Capsule filling machines
3. Syringe and injection device lubrication
4. Medical device assembly and packaging
Regulatory compliance:
1. FDA guidelines (21 CFR)
2. EU regulations (EU GMP)
3. ISO standards (e.g., ISO 10993)
When selecting pharmaceutical lubricants, consider factors like compatibility, regulatory compliance, and manufacturer reputation to ensure product safety and quality.