CRCST Preparation and Packaging Study Guide

What this domain covers

Preparation and Packaging is about 21% of the CRCST exam. It covers the work between the clean side of the washer and the sterilizer door. That means inspecting instruments, assembling sets, choosing and closing packaging, and labeling. Questions often describe a situation and ask what you should do next. So learn the reason behind each step.

Most packaging rules come back to what a package has to do. It must let the sterilant in, keep microorganisms out afterward, and let the user open it without contaminating the contents.

The prep area and its equipment

The preparation and packaging area is a clean area. It is kept at positive pressure, so air flows out and dust from corridors stays out. The temperature is 68-73 F (20-23 C) and relative humidity is no higher than 60%. Readings out of range are reported so they can be corrected. The departmental considerations guide compares these limits with the other areas.

Before you start, set up the station: clean work surface, working lights and magnifiers, and in-date supplies. Chemical indicators, wraps and pouches have expiration dates and storage needs; expired indicators are not used. Anything dropped on the floor goes back to decontamination, because cleaning is never done in the clean area.

Know the purpose of each tool:

• Heat sealer: seals paper-plastic and Tyvek-type pouches. A good seal depends on temperature, pressure and dwell time. Seals should be even, with no wrinkles, channels or gaps.
• Insulation tester: finds breaks in the coating of insulated laparoscopic and electrosurgical instruments. Test every time the instrument is processed, along with a visual check.
• Borescope or scope inspector: a small camera for looking inside lumens and channels for soil or damage.
• Lighted magnification: for spotting cracks, burrs, pitting and soil in box locks and serrations.

Lift heavy trays with the load close to your body, use your legs, and turn with your feet instead of twisting.

Inspection and function testing

Inspection is the check on cleaning. Any instrument with visible soil goes back to decontamination (see the cleaning and decontamination guide). Then check that each instrument works.

• Ratchets: close on the first tooth and tap the ratchet lightly. It should hold. If it springs open, it needs repair.
• Jaws and tips: jaws meet evenly and tips line up. Look for cracks in box locks, burrs and pitting.
• Scissors: cut the test material the manufacturer specifies. Sharp scissors cut cleanly at the tips.
• Needle holders: a needle clamped in the locked jaws should not turn easily. If it does, the jaws or inserts are worn.
• Light cables: dark spots seen when light is passed through mean broken fibers.
• Powered equipment: inspect hoses and cords for cuts or cracks and test according to the manufacturer's instructions for use (IFU).
• Multipart instruments: reassemble per IFU and test that they work.

Damaged instruments (cracks, flaking plating, failed insulation, worn ratchets) are removed from service, tagged, documented and sent for repair. If no replacement is available, follow the facility's policy for incomplete sets: note the missing item and tell the user area.

Lubrication: use a water-soluble instrument lubricant per IFU on hinged instruments that feel stiff, then retest. Never use mineral oil or silicone; they leave a film that blocks sterilant.

Instrument metals and identification

Most instruments are stainless steel. 400-series (martensitic) steel can be hardened and is used for cutting and clamping instruments such as scissors and hemostats. 300-series (austenitic) steel is used for non-cutting items such as retractors and basins. The protective chromium oxide film on stainless steel is the passivation layer.

Common markings: gold handles usually mean tungsten carbide inserts, and black handles commonly mean "super cut" scissors. Identification tape must lie flat. Tape that lifts or peels is removed and the instrument is re-marked.

Expect identification questions, such as telling Metzenbaum (delicate tissue) from Mayo (heavy tissue and suture) scissors. More instrument names are in the professional development guide.

Assembling the set

Assemble every set to its count sheet. Do not leave extra items in a set, and do not substitute unless policy allows it. Any substitution or missing item is recorded. Loaner sets must arrive with the manufacturer's written IFU and a content list.

Placement rules to know:

• Instruments open and unlocked, on stringers or racks, so sterilant reaches every surface and box locks are not stressed.
• Multipart instruments disassembled or assembled exactly as the IFU states.
• Heavy items on the bottom, delicate items on top or in holders.
• Concave items (cups, basins) placed so water drains, not facing up.
• Tip protectors only if steam-permeable, validated for the method, and not so tight that they seal off the tips.
• Nested basins: at least a 1-inch difference in diameter, absorbent material between them, all facing the same way.

Weight limits: an instrument set may weigh no more than 25 lb (about 11.3 kg), including the container or wrap. A wrapped basin set may weigh no more than 7 lb (3 kg). Heavy sets are hard to dry and hard to lift safely.

Chemical indicators

Know the ISO 11140-1 classes:

An internal indicator goes in the part of the package hardest for the sterilant to reach, as the IFU states. That may be the geometric center or opposite corners of a container. Multi-level sets get one in each level. Every package also needs an external indicator unless the internal one can be seen from outside.

Use indicators made for the sterilization method you are using; a steam indicator does not belong in a hydrogen peroxide package. No chemical indicator proves sterility. Biological indicators and the Bowie-Dick test are covered in the sterilization process guide.

Tip from Andrew Hector Smith: When you place the internal indicator, picture where steam would have the hardest time getting in. In a wrapped set that is usually the middle. In a container, check the IFU every time, because each design is different.

Choosing packaging

Packaging must be cleared and validated for the sterilization method and cycle. Steam can use woven textiles, paper and nonwoven wraps, paper-plastic pouches and rigid containers. Hydrogen peroxide gas plasma and vaporized hydrogen peroxide cannot use cellulose (paper, linen, cotton) or liquids and powders. Use Tyvek-type pouches, polypropylene wrap and compatible trays or containers, including any tray liner.

Reusable woven wraps are laundered between uses, inspected over a light table, and repaired only with heat-sealed patches, never stitches.

Wrapping

• Envelope fold for small packs, square fold for large packs. Leave a small tab on the last flap for aseptic opening.
• Sequential wrapping: two separate wraps, one after the other.
• Simultaneous wrapping: one double-layer (often bonded) wrap folded once.
• Wraps go on snug but not tight. Close with sterilization indicator tape, never pins, staples, paper clips or rubber bands.

Peel pouches

Use pouches for light items only, and choose a size that does not stress the seals. When double pouching, the inner pouch is smaller, not folded, and placed paper to paper. Do not put pouches inside wrapped sets or containers unless the manufacturers have validated it.

Rigid containers

Inspect gaskets, filters or valves, latches and locks before each use. Replace single-use filters every cycle. Tamper-evident locks show whether the container was opened. Use a container only in the cycles its IFU lists; the 25 lb limit still applies.

Package inspection and labeling

Before a package goes to the sterilizer, check it for holes, tears and punctures. Seals must be intact and closures secure, with indicators and labels present. Any defect means repackaging; tape is never a repair.

Write on indicator tape or a sterilization label with a felt-tip, non-toxic, indelible marker. Never write directly on the wrap. On pouches, write on the plastic side. A label includes the contents, the load (lot) number, the date, technician initials and destination. Add implant or loaner identifiers when needed.

Test yourself with the free preparation and packaging practice questions, each with the answer explained. To see which domain to study first, take the free CRCST diagnostic test.

Sources

The Preparation and Packaging questions cite these documents, by document and, where we can confirm it, chapter or section. We never reproduce them.

1. HSPA Sterile Processing Technical Manual (63 questions)
2. ANSI/AAMI ST79 (26 questions)
3. ANSI/AAMI ST77 (5 questions)
4. ANSI/AAMI ST58 (2 questions)
5. ISO 11140-1 (2 questions)

Found a mistake? Use "Report a problem" under any question, and Andrew Hector Smith checks it.

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