Quality Control Parameters for Glass Containers

Here is the types of glass containers used in the pharmaceutical industry:

Glass Type	Name	Chemical Resistance	Common Pharmaceutical Applications
Type I	Borosilicate Glass	Highest	Injectable products, parenteral preparations, sensitive drugs
Type II	Treated Soda-Lime Glass	High (Treated)	Acidic or neutral injectables, infusions
Type III	Regular Soda-Lime Glass	Moderate	Oral liquids, tablets, capsules, powders
Type NP	General-Purpose Soda-Lime Glass	Lowest	Topical preparations, oral products not sensitive to glass interactions

Hydrolytic Resistance (Chemical Resistance)
- Evaluates how much alkali is extracted from the glass surface when exposed to water.
- Testing involves:
  - Washing the container
  - Filling with purified water
  - Autoclaving
  - Titrating the solution to measure extracted alkali
- Used to classify glass into Type I, Type II, or Type III based on resistance.
Arsenic Content Test
- Ensures glass does not leach harmful levels of arsenic.
- Older glass formulations contained trace heavy metals, requiring compliance with pharmacopeial limits.
Internal Surface pH Test
- Determines if the container’s inner surface alters the product’s pH.
- Similar to hydrolytic resistance testing but focuses on pH shifts that could impact drug stability.
Light Transmission Test
- Ensures amber or colored glass provides adequate UV and visible light protection.
- Conducted using a spectrophotometer.
Fragmentation Test (for Ampoules)
- Assesses the tendency of ampoules to produce glass particles upon breaking.
- Critical for injectable products to minimize glass particulates.
Mechanical Strength / Breakage Resistance
- Evaluates the container’s ability to withstand mechanical stress, including:
  - Vertical load resistance
  - Impact resistance