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What should I look for in an MDI canister manufacturer?

Look for three things in an MDI canister manufacturer: deep-draw dimensional control held at volume, an inner surface matched to the formulation (anodized for solutions, plasma coated for suspensions), and leachable and extractable data ready for your regulatory file.

A metered-dose inhaler (MDI) canister is a deep-drawn aluminum container that holds the pressurized formulation and seats the metering valve. It looks simple, but every dose the patient receives depends on the canister holding its dimensions and keeping the formula off its walls for the full shelf life.

That is why the choice of supplier is really a choice of three capabilities: forming precision, inner-surface technology and documentation.

The canister is not packaging around the drug — it is part of how the dose is delivered.

Formulation type decides the inner surface. Solution formulations benefit from an anodized canister: Anomatic's patented anodization grows an even anodic film that acts as a barrier for sensitive formulas and significantly improves impurity levels. Suspension formulations benefit from FCP plasma coating, which leaves a hydrophobic surface with a contact angle above 100 degrees so particles do not stick to the wall — without changing the canister's dimensions.

Anomatic deep-draws MDI canisters in standard 10, 14, 17 and 19 ml sizes, with custom sizes available, at an annual capacity of more than 2.5 billion parts. Pharmaceutical components are produced under cGMP at our Center of Excellence for Inhalation and Pharmaceutical Packaging in Suzhou, China, and are engineered to fit your chosen valves, devices and filling lines.

Questions to ask a canister supplier

  1. Which inner surface do you recommend for a solution versus a suspension formulation?
  2. Can you share leachable and extractable studies for that surface?
  3. What standard sizes do you run, and can you tool a custom size?
  4. How is dimensional control held from first article to final pallet?
  5. Are pharmaceutical components produced under cGMP?

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