Sterile single-use products must be sterilised with a validated method. The method affects materials, packaging and labelling. Different sterilisation methods therefore suit different products.
| Method | How it works | Notes |
|---|---|---|
| Ethylene oxide (EO) | A gas that kills microorganisms at low temperature | Suits mixed materials and plastics; needs time to remove gas residues |
| Gamma radiation | Radiation passes through sealed packs | Fast, no residues; some plastics change colour or weaken |
| Steam | High-temperature steam under pressure | Common for metal; not for heat-sensitive materials |
What buyers should ask
- Which method is used, and is it validated?
- Who carries out sterilisation, in-house or a contract sterilizer?
- What sterility assurance level is claimed?
- How is each batch released?
Labelling
The label shows the method with a standard symbol, for example “STERILE EO” or “STERILE R” for radiation.
Comparing sterilisation methods
Each of the main sterilisation methods has strengths and limits. For example, ethylene oxide works at low temperature, so it suits plastics. However, it needs time for the gas to clear. In contrast, gamma radiation is fast and leaves no residue, but some plastics change colour. Steam is simple and cheap, yet it needs heat-resistant materials.
Therefore, ask your supplier which method they use and why. Also, ask for the validation report. As a result, you can be sure the method fits the product.
The sterilisation overview explains each method in detail. To discuss sterilisation methods for your kits, contact our team.
Sterile products from Tata Surgical
Ask us which sterilisation method is used for each sterile product.
Looking for instruments like these?
Browse our catalogue or send us your drawing. We reply with prices, lead time and shipping terms.
