Introduction:
In pharmaceutical manufacturing, primary packaging plays a vital role in preserving the stability, efficacy, and safety of the final product throughout its shelf life. For semisolid dosage forms such as ointments, creams, and gels, aluminium tubes are widely used due to their excellent barrier properties, lightweight nature, and ability to protect formulations from light, oxygen, and moisture.
However, the use of aluminium as a packaging material also introduces specific risks that must be carefully evaluated to ensure compatibility with the formulation, compliance with regulatory standards, and protection against product degradation or contamination. Factors such as interaction between the formulation and the metal, tube integrity, lamination quality, internal coating performance, and crimping or closure defects can affect product quality.
Improper selection, handling, or monitoring of aluminium tubes can lead to the following issues:
- Leaching or chemical interaction between the formulation and the aluminium surface
- Corrosion or pitting, especially in formulations with high water content or acidic pH
- Loss of product integrity due to pinholes, improper sealing, or poor crimping
- Particulate contamination from delamination or coating defects
- Deformation during transport or storage that affects dosing or usability
This risk assessment aims to systematically identify and evaluate the risks associated with the use of aluminium tubes for ointment packaging. Using structured methodologies such as 6M analysis (Man, Machine, Method, Material, Measurement, Milieu) and FMEA (Failure Modes and Effects Analysis), the assessment will focus on:
- Material compatibility between the ointment base and tube interior
- Adequacy of internal lacquer or coating to prevent interaction
- Quality controls in tube manufacturing and packaging operations
- Risk of contamination, migration, or mechanical damage
- Regulatory and pharmacopoeial compliance of packaging materials
The objective is to ensure that aluminium tubes are suitable, safe, and compliant for use as primary packaging for ointments, thereby maintaining product quality, protecting patient health, and aligning with GMP and ICH Q8/Q9 guidelines.
