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Packaging

Objectives and principles of packaging

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Packaging is intended to preserves the sterility of the reusable medical device (RMD) after sterilization until its use.

explanations

International standard ISO 11607-1 defines packaging functions as follows :

  • The Sterile Barrier System (SBS) is “the minimum package that minimizes the ingress of microorganism and allows aseptic presentation of the sterile contents at the point of use”.
  • The protective packaging (PP) is “the configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use”.
  • The packaging system (PS) is “the combination of a sterile barrier system and protective packaging”.

The sterile barrier system (SBS):

  • allows the free circulation of the sterilizing agent and extraction of condensate or chemical residues and resists to high temperature (when applicable) and pressure variations,
  • does not produce any toxic by-products or particles,
  • protects its contents from contamination (microorganisms and dust) until use,
  • allows for the aseptic presentation of the medical device.

  • The packaging system is adapted to the size, weight, shape and configuration of the RMD or RMD composition.
  • The packaging system ensures the physical protection the RMD and SBS during handling, transport and storage. If needed, RMDs are installed in a tray. Adapted accessories or instrument organizers protect the device and avoid breach of the SBS by sharp edges.
  • As needed, the SBS is inserted into protective packaging. If the protective packaging is installed before sterilization, it must be compatible with the sterilizing agent. Contaminated protective packaging is removed before entry in the sterile area.
  • If the SBS must be sterile to allow extraction of the RMD by sterilization personnel, the protective packaging is also a sterile barrier system (SBS).

Choice of the packaging technology

4 technologies of sterile barriers systems are available on the market

  1. Single use wraps are made of woven or nonwoven cellulosic, synthetic or mixed cellulosic/synthetic sheets. Wraps are commonly used for baskets and intrument sets. Wraps manufacturers define the number of wrap layers required to meet resistance and microbial barrier criteria. Wrap layers may be independent (sequential) or pre-
    Various folding methods are used (e.g., envelope, square or parcel or parallel, roll or pasteur). Method is chosen with surgical department and once agreed, is performed in the same manner by all operators of the sterilization department. Folding is secured by adhesive tapes which usually also serve as sterilization indicators. .
  2. Single use pouches or reels are made of 2 sheets presealed on 3 sides (pouches) or 2 sides (reel). Pouches and reels are available in various dimensions and strengths. Rolls of reels are cut at the desired length.
    At least one side of the pouch or reel is permeable to the sterilizing agent. The permeable side is made of nonwoven cellulose, synthetic or mixed cellulose/synthetic material. The other side is a transparent film (usually not permeable to the sterilizing agent).
    Pouches and reels are commonly used for light weight instruments or trays.
    Closure of pouches or reels is preferably done by heat sealing. By default, when heat sealing equipment is not available, pouches with self-sealing adhesives can be used.
  3. Reusable containers (box and lid) are made of aluminium, stainless steel or high-density polymers. Containers are available in various standardized sizes and often used with multiple baskets or set compositions. A sterilizing agent penetrates through a filter, single use (most frequent) or reusable. Cleaning and disinfection of containers is as defined by the container’s manufacturer IFU, and requires organization, supplies and equipment. Maintenance plans are in place.
    Before reprocessing, disposable items are discarded and reusable accessories are disassembled. Container gaskets, mating surfaces, and latching mechanisms are visually inspected very carefully for cleanliness, distortion, impact, defect (which could impair the sealing), filtering, and locking functions. Dirty containers are cleaned again. Damaged containers are sent for repair.
    Many manufacturers recommend single use filters.  Reusable filters are inspected and discarded if defective. If manufacturers specify a maximum number of reprocessing cycles, the filters are discarded when this number is reached.
  4. Reusable textiles are made of cotton. Like single use wraps, they are mainly used for baskets and instrument sets.
    Barrier performances of traditional cotton wraps are poor and deteriorate by repeated laundering and sterilization. Visual inspection for holes and tears are at risk for human error, which is not reliable. Textile release particles which may pollute RMDs or spread in the sterile area during extraction
wfhss

Reusable textiles do not meet normative requirements and cannot be considered as sterile barrier systems. If textiles are used, packaging operations must take place in a separate room.

Polyester reusable wraps have better initial barrier performance than cotton. Evidence must be provided by the manufacturer that the sterile barrier performance remains satisfactory over the allowed number of reuses. Means must be provided to control the number of reuses. Controls should be performed by trained personnel in conditions that minimize the risks of errors.

Performance of SBS and SBS material are defined by international standards. There is no international standard for cotton textile wraps.

wfhss

International standards ISO 11607-1 and 11607-2 describe criteria and methods to test the packaging design, material and closure (resistance, permeability to air, biocompatibility, aging etc..). Different methods are proposed. For example, there is no unique universally accepted test for sterile barrier properties. Manufacturers may use one or several methods and test internally or with support of external laboratories. Methods which provide clear pass or fail criteria are preferred.

The packaging process

Packaging takes place in a controlled environment. The space allocated to packaging operations is separated from the cleaning area. Air quality  is determined by local regulations or best practices.

Packaging must be performed without delay after control & assembly

There is no unique way to correctly package a given RMD. The packaging process is defined by risk analysis in partnership with the surgical or medical user, according to RMD characteristics and logistic considerations.

explanations

For example, a general hospital with an internal sterilization department will not have the same imperative as a specialized surgery center with outsourced reprocessing. Local recommendations or regulations may also apply.

Written standard operating procedures (SOP) describe each step of the packaging process.

SOPs include RMD and packaging manufacturers’ IFUs.

  • Expiration dates (for single use packages)or maximum number of reuses (for reusable containers) are checked. Expiration dates of packaging are event-related. For example, the maximum number of reuses of a container may be reduced if risk analysis or experience shows that logistic and handling risk are high. Expired packages are discarded according to waste management procedures, and/or manufacturers’ IFUs,  local regulations, or all three entities.
  • Packaging items are visually controlled. Wraps, pouches, reels with holes are discarded according to manufacturers’ IFUs and local regulations. Container gaskets, mating surfaces, and latching mechanisms are inspected for cleanliness, distortion, impact, defect (which could impair the sealing), filtering or locking functions. Dirty containers are re-cleaned. Damaged containers are sent for repair. Reusable filters are inspected and discarded if defective.
  • Before insertion in an SBS, RMDs are, as needed, equipped with protection accessories, and installed in a basket, tray or organizers. Protection and organizers ease aseptic presentation and limit the risk of operator injuries. For pouches and reels, handles are on opening side, and sharp edges are on the opposite side. In trays, instruments with concave surfaces are positioned on their side to ease diffusion of the sterilizing agent, and allow for moisture to collect in the concave portion to drain (for moist heat sterilization).
  • SBSs are hermetically closed. Container lids are fastened with tamper-evident indicators. Wraps are folded with appropriate methods. Pouches and reels are  Temperature of sealing machine is set in accordance with pouch and reel manufacturers’ instructions. If required per the risk analysis, additional layers of pouch, reel or wrap are implemented with similar precautions.
  • Packaging items carries individual labeling. Labels are visible (i.e. on an external wrap, in case of double wrap). If a protective package (PP) contains several SBSs, means are provided to identify the SBS enclosed in the PP. For pouches and reels, the label is placed on the non-permeable side. Writing or printing on the porous web is not allowed, as ink could seep through the packaging. Conversely, writing or printing on the porous web which does not come in direct contact with the medical device is allowed. Each container carries a traceability tag. Labels are compatible with the sterilization process. Expiration dates are defined according to SOPs.
  • After sterilization, each item is visually controlled. Damages, non-conformities and missing or incomplete labels are reported and analyzed. Visible damage on external pouch, reel or wrap is an incentive to check damages of the internal SBS. As needed, RMDs are repackaged and sterilized or cleaned and sterilized. A root cause analysis should be performed and the risk control measures should be adapted accordingly.
  • As needed, protective packaging (post sterilization) is implemented. If a protective packaging includes several SBSs, contents of the protective packaging is visibly indicated.
  • Transport and storage of packages are performed with care and according to manufacturer instructions.
  • At point-of-use, packages are visually inspected. RMD is aseptically extracted by trained operators.

Packaging and quality management

Written packaging standard operating procedures (SOP) are prepared in accordance with quality management principles.

A SOP is available for each group of RMD’s sharing a common packaging process (i.e. same sterilization procedure, same type of SBS, protective measures for transport and storage).

Each SOP is based on a thorough step-by-step risk analysis from package preparation to aseptic presentation. The risk analysis is challenged by a real life test in worst case conditions for each type of representative packaging.

Packaging process validation controls that:

  • The packaging area of the sterilization facilities is adequately designed and installed  (e.g. including lighting, packaging workstation etc.) and that air quality is appropriate and monitored.
  • Sealing equipment is properly installed and calibrated.
  • Manufacturer’s  instructions for use (IFU)for SBS and heat sealing equipments are available.
  • Certificates of compliance with international standards and certificates of tests performed to claim compliance are provided.
  • SOP’s are up to date
  • Occupational health and safety considerations are included. Packaging facilities and workstations are adequately designed, installed and equipped; precautions are taken against injuries by sharp RMD’s or excessive loads. The maximum total weight of a packaged items does not exceed 10 kg (including the container, if that type of reusable SBS is used)
  • Training is executed and certificates are available.

Recommendation of WFHSS for packaging process

  1. The sterile barrier system (SBS) complies to international standards and must be compatible with the sterilization process and cycle (exposure to the sterilizing agent and pressure variations do not alter SBS properties and produce no toxic by-products).
  2. The packaging system (SBS and protective packaging) preserves the SBS and its contents until use and allows for the aseptic extraction of the RMD.
  3. The packaging process standard operating procedure is established by risk analysis in partnership with the user. It undergoes process validation and is implemented by trained operators.
  4. Cotton textiles should not be used.
  5. Maintenance contracts are in place for heat sealers; seal quality is periodically verified by appropriate tests. Containers are controlled and maintained.
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