Sterility Validation Data: Sterilization and Storage Documentation Requirements

1. Key takeaways

Article 21 of DS 825/1998 lists sterilization and storage information among the basic requirements for Class I devices, covering four elements: sterilization method, sterilization controls, shelf life and storage conditions. At the same time, Exempt Decree No. 25/2026 brings steam and ethylene oxide sterilization equipment itself into the controlled list — sterilization is both a documentation requirement and a product category, and sponsors may face it from both directions at once.

GRZAN flags two high-frequency failure points: the sterile batch certificate must be apostilled, and the shelf life and storage conditions must match the Spanish label exactly. Both failures are administrative rather than technical, which makes them inexcusable and, unfortunately, common. A third failure point is less visible: storage conditions stated as ranges broader than what the stability data support, which the reviewer reconciles against the label and the sterilization claims.

2. Legal basis

• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 21(a), point 3: sterilization and storage information — sterilization method, sterilization controls, shelf life, storage conditions.
• Same instrument | Article 21(a), point 1 | product identification information includes batch numbers and coding.
• ISP procedure | prestación 9100003 (v3, September 25, 2025) | a sterile batch certificate must be submitted for the batch declared (cuando corresponda), and must be legalized or apostilled.
• Decree listing devices under the sanitary control regime of Article 111 | Decreto Exento N° 25, de 2026 | March 19, 2026 | brings steam or ethylene oxide sterilization equipment into scope (Class II).
• Same instrument | amendment clause | significant changes in design, manufacture or intended use that affect quality, safety or performance require a new registration application.

3. Expert insights

Insight one: sterilization information is a base-layer item, not a privilege of sterile products.

The provision places it among the six Class I basic requirements. Non-sterile products must still answer this item — the correct response is to state that it does not apply and explain why, not to leave the field blank. A blank is read as an incomplete dossier. A one-paragraph statement of non-applicability costs minutes to write and removes an entire class of deficiency queries about completeness. The statement should sit in the same section as the four items, so the completeness check finds it without a search.

Insight two: a change of sterilization method is a significant change that can trigger re-registration.

Exempt Decree No. 25/2026 lists changes affecting quality, safety or performance as situations requiring a new registration application. Changing the sterilization method directly affects the safety of the product, so it almost inevitably falls into the significant-change category. GRZAN recommends listing sterilization method changes under the high-risk row of the change impact assessment form, so that any such change immediately triggers a regulatory evaluation rather than a retrospective discovery during an inspection or a labeling update. The evaluation should distinguish changes of agent, of validation status and of cycle parameters, because each carries a different documentary cost.

Insight three: the sterile batch certificate is a per-batch document, and it must be legalized.

The procedure requires a certificate of sterility for the declared batch, apostilled. This means once the declared batch is fixed, it should not be switched midway: a change forces the certificate to be obtained again, a cycle measured in weeks given notarization, legalization and shipping times. Batch selection is therefore a scheduling decision, and it belongs on the project plan next to the submission date, not in the packaging department’s queue. Plan the certificate lead time — notarization, apostille and courier — backward from the filing date with at least a month of margin.

Insight four: the equipment itself is now listed, creating a dual submission of equipment plus consumables.

Steam and ethylene oxide sterilization equipment is listed as Class II. A company exporting both sterilization equipment and consumables sterilized by that equipment must evaluate the two lines separately — the equipment follows the Class II 36-month transition period, while the consumables follow whatever class their own classification produces. Treating the two lines as one project risks miscalculating both the deadlines and the dossier scope for each. Consumables whose claims depend on a specific sterilization cycle should also cite that cycle consistently in their own labeling, so the two dossiers corroborate rather than contradict each other.

4. Practical recommendations

1. For non-sterile products, state the non-applicability of the sterilization item in writing with reasons; never leave it blank.
2. Complete the Apostille for the sterile batch certificate in one pass, and fix the declared batch before filing so it does not need to change.
3. Match the shelf life and storage conditions to the Spanish label word for word, with a documented comparison check.
4. List sterilization method changes as a high-risk row of the change impact assessment form, evaluating re-registration requirements at the moment of change.
5. Evaluate sterilization equipment and consumables as two separate lines, each with its own class determination and transition period.

5. Verification checklist

• □ The four items of Article 21(a) point 3 — method, controls, shelf life, storage conditions — are prepared
• □ Non-sterile products have a written statement of non-applicability with reasons
• □ The sterile batch certificate has been apostilled
• □ The shelf life and storage conditions have been checked word for word against the Spanish label
• □ Sterilization method changes are listed as a high-risk row of the change impact assessment form

Regulatory information verified as of October 29, 2026.

For a product-specific feasibility assessment of Chile market entry, GRZAN’s regulatory team supports manufacturers and importers with registration dossiers, conformity documentation and ISP submissions. Contact info@grzanglobal.com to discuss your project.