Pharmaceutical ampoules are primary containers derived from glass tubes of the first Hydrolytic Class. It is fundamental that quality, chemical-physical, cleaning and dimensional features are in compliance with their foreseen usage.

An acceptance quality level (AQL) is assigned to every defect with reference to the "Statistical Quality Control" according with MIL-STD.

Every deviation from standards, specifications or drawings is considered as a defect. Such defects are classified as follows:

1. Unadmitted defects are defects which could endanger human health and life, break laws, destroy or deteriorate the contained product.
   
   
2. Critical defects are defects which could cause a functional inefficiency and consequently a deficiency of materials and packaging means, or that push users to complain.
   
   
3. Primary defects are defects which could cause a productive reduction or a deterioration of productive means, of filling systems or packaging systems.
   
   
4. Secondary defects are defects which could cause a reduction in the general quality.

The Quality level foreseen for the empty ampoules corresponds, in relation to the above defects, to the following acceptable quality level (AQL):

General list of Unadmitted, Critical, Primary and secondary defects.

Unadmitted : Uncomplaint hydrolytic resistance.

Critical AQL 0.25% : Poor resistance to the thermal shock, stress presence, inside presence of particles from glass origin in closed ampoules, internal presence of foreign particles of non-glass origin, cracks, full breaking point lackness, missing O.P.C. colour-point, wrong colour for O.P.C point or colour-break, unrequired siliconization presence, Full siliconization lackness, rounded bottom, full or partial bottom lackness, out-of-tolerence bottom perpendicularly (lyoph.pr. only), non-hermetical stem soldering (only for closed ampoule), closed mouth or excessive glazing at the tip.

Primary AQL 1.5% : Inclusions and gas-bubbles over 1 mm, dimensional out-of-tolerance O.P.C. Colour-point, out-of-axis OPC colour point, out-of-tolerence breaking point loads (standard only), breaking point colour disanchorage, out-of-tolerance body diameter, out-of-tolerance body glass thickness, out-of-tolerance bottom perpendicularity, out-of-tolerance bottom thickness, out-of-tolerance stem centering, out-of-tolerance stem diameter, out-of-tolerance stem glass thickness, out-of-tolerance ampoule type D closing diameter, out-of-tolerance constriction diameter, out-of-tolerance constriction glass thickness.

Secondary AQL 4% : Removable dust glass particles or other origin particles, inclusions and gas bubbles 0.5-1 mm. dark spots or dots, out-of-tolerance overall height, assured incomplete breaking point, unburnt stem cutting, cup diameter over maximum limits, intermixture of stem of different size, out-of-tolerance bulb diameter, out-of-tolerance contriction height.