RKI Instrument Packaging

Packaging critical instruments preserves their sterility until the point of use. It forms the sterile barrier system (SBS), which keeps out dust, moisture and micro-organisms after sterilization. Packaging materials must meet the requirements of DIN EN ISO 11607-1 (or the DIN EN 868 series) and must be declared suitable by the manufacturer for the chosen sterilization method (e.g. steam at 134 degrees C). The sealing process must be validated in accordance with DIN EN ISO 11607-2.

1What is a sterile barrier system (SBS)?

An SBS is the sealed packaging that protects the sterile instrument from recontamination until the point of use (e.g. a transparent sterilization pouch or a container). It must form a microbial barrier, allow steam penetration, and permit aseptic opening. Requirements for materials and processes are governed by DIN EN ISO 11607-1 (materials/systems) and -2 (validation of the packaging process).

2Common packaging types

3The seal seam – and why it must be inspected

The seal seam is the most critical point of the packaging. It must be continuous, wrinkle-free and firm. A validated sealing process (temperature, contact pressure, speed) must be demonstrated in accordance with DIN EN ISO 11607-2. During routine operation, inspect the seam regularly:

Daily: Seal check / ink test, visual inspection of the seam (uniform contrast, sharp contours) and peel test (paper separates from the film with virtually no residue).
Periodically: Tensile strength testing of the seam.

Important additional points per RKI & standards

These points are frequently overlooked in practice but are essential for correct and legally compliant implementation:

• Process/treatment indicator on the packaging: Use sterilization packaging with an integrated process indicator (treatment indicator) or apply one separately. The colour change confirms that the package has been through the sterilization process and distinguishes processed from unprocessed sterile goods. Visual inspection of the indicator is part of the batch-related checks and the release procedure.Source: KRINKO/BfArM 2012, Appendix 'Notes on the use of chemical indicators' (Class 1 process indicators) and Section 2.2.6 (process indicators for labelling)
• Labelling in the course of sterilization and release: During packaging, non-critical preliminary labelling (e.g. contents) may be applied outside the seal seam and only on the paper side. The labelling-relevant information – sterilization date or batch identification, expiry date or sterile shelf life where applicable, and the release decision – is documented on the packaging in the course of sterilization and release, not in advance during packing. This batch- and release-related documentation (batch documentation) can be completed in just a few clicks with the free ClavioSoft – stored in a tamper-proof format.Source: KRINKO/BfArM 2012, Section 2.2.6 (labelling: sterilization date, batch identification, expiry date, sterile shelf life, release decision)
• Mandatory inspection of the packaging immediately before use: Regardless of batch-related checks, the packaging must be inspected again immediately before each use (dryness, integrity, intact seal seams, valid labelling). If the packaging is damaged, moist or the labelling is invalid, the instrument must not be used but must be reprocessed and repackaged.Source: KRINKO/BfArM 2012, Section 2.2.4 ('Obligation to inspect immediately before use') and Annex 4 (batch-related checks – visual inspection of packaging: dryness, integrity, intact seal seams, complete labelling)
• Sterile shelf life depends on packaging and storage conditions: Sterile goods must be stored dust-free, clean, dry and at room temperature. The permissible storage period depends on the quality of the packaging material, the tightness of the seal seams and the storage conditions; under favourable conditions, shelf lives of more than six months are possible. Define the shelf life within your facility and take into account the information provided by the manufacturers of both the medical device and the packaging material.Source: KRINKO/BfArM 2012, Section 3 (transport and storage): dust-free/clean/dry, storage period depends on packaging quality, seal tightness and storage conditions, shelf lives of more than six months feasible
• Dryness of sterile goods before packaging: Only instruments that have been thoroughly cleaned, disinfected and dried may be packaged. Residual moisture under the film compromises the sterile barrier and shelf life and may cause corrosion. Before packaging, check cleanliness, dryness and functionality (e.g. place hinged instruments in the open position).Source: KRINKO/BfArM 2012, Sections 2.2.1/2.2.4 (inadequate drying as a source of error; visual check for dryness) and Annex 4 (place instruments with open hinges/joints)
• Packaging process as a validated, SOP-governed part of the overall process: The packaging step is part of the reprocessing procedure that, under the MPBetreibV, must be carried out using suitable validated methods and by personnel with the required expertise, and must be defined in a standard operating procedure (SOP). Heat sealers must be validated and maintained in accordance with the manufacturer's instructions; the critical parameters (in particular temperature and contact pressure) must be set and documented. The SOP and ongoing documentation can be managed quickly and easily with the free ClavioSoft.Source: MPBetreibV (reprocessing with validated methods); KRINKO/BfArM 2012, Annex 4 (heat sealers: critical process parameters temperature and contact pressure, operating instructions must be available; prepare standard operating procedure); DIN EN ISO 11607-2

Required equipment, consumables & accessories

Checklist for this step – items you should have on hand (shopping list):

Templates & sources

1. KRINKO/BfArM 2012, Bundesgesundheitsbl. 55:1244–1310 – Section 2.2.4.
2. DIN EN ISO 11607-1/-2; DGSV guideline on validation of packaging processes.
3. DIN 58953 (sterile supply management); routine operation checklist for sealing devices; MPBetreibV § 8.