Best Practices

Consider the purity of exhaust air emitted by vacuum pumps in addition to the purity of compressed air used in the pharmaceutical process.

Best practices for buying, selling, and transporting second-user equipment.

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

Preheating pinch valves prevents drift in the volume of liquid dispensed.

Highly potent or cytotoxic drugs require special handling

Texture analyzers can be used to evaluate wall hardness and elasticity of softgel capsules.

Non-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.

Consider the 3 Ps (product, process, and patient) when choosing a parenteral packaging material.

Advanced electronic batch recording (EBR) manages workflows and recordkeeping for compliance and production efficiency.

Wear-resistant materials and coatings protect tablet punches and dies from abrasive formulations.

Dedusting equipment and techniques address problems associated with tablet manufacturing dust accumulation.

Tablet presses require regular inspection and maintenance to prevent premature wear and tableting problems.

Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.

Regular removal of residues from disinfectants and sporicidals is important for improved aesthetics and safety in cleanrooms.

When implementing disposable technology for aseptic processing, considerations include material compatibility, material sourcing, facility layout, and training.

Pharmaceutical manufacturing facilities can help prevent contamination and cross contamination by using color coding.

Dynamic powder testing and measurement of bulk powder properties can complement shear cell testing to identify the causes of poor hopper performance in solid-dosage drug manufacturing.