The quality system requirements that govern medical device manufacturing under ISO 13485 treat raw materials — including adhesives — not as commodities that are received and used, but as controlled inputs whose identity, condition, and traceability through the production process must be documented and maintained. For an epoxy adhesive used in device production, this means that every lot used in manufacturing must be verified to be within its shelf life, documented in the device history record (DHR), and traceable forward to the specific devices manufactured with that lot and backward to the certificate of analysis that confirms its tested properties. Shelf life management and traceability are not optional documentation practices — they are requirements that directly affect device lot disposition and regulatory compliance, and gaps in either can result in field actions if a material quality issue is identified after distribution.
What Shelf Life Documentation Requires
Shelf life for a two-component epoxy adhesive is the period during which the product, stored under specified conditions, maintains properties within the specification limits. At the end of shelf life, the adhesive may have advanced in partial cure, changed viscosity, precipitated or settled, or undergone chemical changes that alter its cure characteristics or final mechanical properties.
The shelf life claim must be based on demonstrated data — stability testing of the product under the specified storage conditions for the full claimed shelf life period, with properties measured at intervals and confirmed to remain within specification. For a medical-grade epoxy with a 24-month ambient-temperature shelf life claim, the supplier must have conducted stability testing that confirms the product meets specification throughout 24 months of storage at the specified temperature range.
In production, the manufacturer must verify that each received lot is within its stated shelf life before use. This is done by comparing the lot expiration date from the certificate of analysis against the date of planned use. A lot received with 6 months of shelf life remaining must be used or managed to ensure it is consumed before expiration.
If a lot is received past its expiration date, or if a lot in storage expires before it is used, the material must be quarantined, removed from the approved inventory, and either returned to the supplier, retested against acceptance criteria with a new shelf life determination if testing is feasible, or scrapped. Using expired material in production — even material that appears visually unchanged — is a nonconformance under ISO 13485 and potentially a violation of device regulations if the device is distributed.
Certificate of Analysis Content Requirements
The certificate of analysis (CoA) from the adhesive supplier provides the documentation basis for the received lot. For a medical-grade epoxy used in ISO 13485-compliant production, the CoA must include:
Product name and part number, clearly identifying the specific formulation.
Lot number, unique to the manufacturing batch, traceable back to the supplier’s manufacturing records.
Manufacturing date and expiration date (or shelf life from manufacturing date), defining the usability window.
Tested properties with results, specifications, and test methods for each property covered by the specification. Typical properties include: viscosity (individual components and mixed), mixing ratio (confirmed or specified), color, gel time or pot life, and any mechanical or physical properties included in the product specification.
Compliance statement or signature confirming that the lot meets the specification requirements.
For medical-grade products, the CoA may also reference the biocompatibility data package by version number, confirming that the lot was manufactured to the same formulation that was tested for biocompatibility.
For CoA format and content for specific Incure medical-grade epoxy products, Email Us — Incure can provide documentation in formats compatible with ISO 13485 material traceability requirements.
Lot Traceability in Device Production Records
Each device produced must have a device history record (DHR) that documents the materials used in its construction, per FDA 21 CFR Part 820 and ISO 13485. For adhesives, the DHR entry includes: the adhesive product name, the lot number used, and confirmation that the lot was within shelf life at the time of use.
In practice, this documentation is maintained in the batch manufacturing record (BMR) or production traveler that accompanies each device or device lot through production. The adhesive lot number is recorded when the material is withdrawn from inventory and issued to production. The BMR is retained in the device history file for the period required by the quality system — typically the device service life plus the post-market surveillance period required by the applicable regulation.
The traceability chain must run in both directions: forward (which devices used this adhesive lot) and backward (what lot was used in this device). Forward traceability enables targeted field notifications if a material quality issue is identified — the manufacturer can determine exactly which devices were produced with the suspect lot. Backward traceability enables investigation of a field complaint — if a device fails in a way consistent with an adhesive issue, the lot used in that device can be identified and tested against the CoA values.
Incoming Inspection and Receiving Procedures
Receiving inspection for medical-grade adhesive involves verifying the physical receipt against the purchase order (correct product, correct quantity, undamaged packaging), documenting the lot number and expiration date, and confirming that the CoA is present, covers the received lot, and shows passing results for all specified properties.
Some manufacturers perform in-house verification testing — viscosity measurement, gel time check, or other simple in-process tests — to confirm that the received lot behaves as expected before releasing it to production. This is particularly valuable for adhesives with properties that affect process parameters: a lot with higher-than-expected viscosity may require adjusted dispense pressure settings, and identifying this at receiving prevents process excursions in production.
Lot quarantine and hold procedures ensure that received adhesive is not issued to production until the CoA review and any in-house verification testing are complete and documented. Material received from the supplier but not yet released to inventory is held in a designated quarantine area, clearly labeled as pending release.
First in, first out (FIFO) management of adhesive inventory ensures that lots received earlier are used before lots received later, minimizing the risk of expiration for lots that sit in storage. Inventory management systems that track lot numbers and expiration dates and generate alerts when lots approach expiration support FIFO compliance.
Contact Our Team to discuss shelf life documentation, certificate of analysis format, and lot traceability procedures for medical-grade epoxy in ISO 13485-compliant medical device production.
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