Laboratory Safety Manual
Reviewed May 2012
A list of cytotoxic/antineoplastic agents for which these procedures must be followed may be found in Appendix
K of this manual.
More information can be found in the OSHA Technical Manual, Section IV - Chapter 2, "Controlling
Occupational Exposure to Hazardous Drugs."
Personal Protective Equipment
It is suggested that all CDs be prepared in one centralized area. If this is not
practical, the number of areas used for preparation should be minimized. If possible, an
isolated BSC, where only CDs are prepared, should be designated. Warning signs designating
the area as a cytotoxic drug preparation area that should not be entered by unauthorized
staff should be clearly posted. Spill procedures should also be posted. Eating, drinking,
smoking, chewing gum, applying cosmetics, and storing food in or near the preparation area
Work with cytotoxics must be carried out in a BSC on a disposable, plastic-backed paper
liner, which should be changed after preparation is completed for the day, or after a
shift, whichever comes first. Syringes and IV sets with Luer-lock fittings should always
be used, and syringes should always be large enough so that they need never be more than
three-fourths full. A non-splash disposal collection vessel such as a plastic or metal
tray lined with sterile gauze pads should be at hand to collect excess solution. All
necessary items should be placed within the BSC before work is begun and all extraneous
items should be kept out of the work area in order to avoid contamination.
- The work areas should be provided with a closeable, puncture-resistant, shatter-proof
container for disposal of contaminated sharp/breakable materials. Labeled sealable plastic
or wire tie bags should be included at hand so that all boxes and other contaminated
materials, including gloves, gowns, and paper liners, can be immediately placed in them
and disposed of as cytotoxic waste as directed by the EHSO.
The cabinet should be cleaned daily with 70% alcohol and decontaminated
weekly, whenever spills occur, or when the cabinet requires service or certification.
Ordinary decontamination procedures, which include fumigation with a germicidal agent, are
inappropriate in a BSC used for CDs because such procedures do not deactivate the drugs
and may cause chemical reactions. Decontamination should consist of surface cleaning with
high-pH agents followed by thorough rinsing. Removable work trays, if present, should be
removed, and the back of the work tray and the sump below should be included in the
Work Practices in Preparation
Proper aseptic techniques are essential for worker protection. It should be noted,
however, that BSC benches differ from horizontal flow units in several ways, thus
requiring special precautions: manipulations should not be performed close to the work
surface and un-sterilized items, including liners and hands, must be kept down-stream from
the working area. Operators should be trained in these techniques.
Syringes and IV Bottles
All syringes, IV bags and bottles containing CDs should be labeled with a distinctive
warning label, such as "Chemotherapy--handle with gloves--dispose of properly."
The use of large-bore needles, #18 or #20, will ensure that high-pressure syringing of the
solutions is avoided. However, some experienced personnel believe that large-bore needles
are more likely to drip. The needle should be chosen with these advantages or
disadvantages in mind.
- Drug administration sets should be attached and primed within the hood, before the drug
is added to the fluid, to obviate the need to prime the set in a less well-controlled
environment, and to ensure that any fluid that escapes during priming contains no drug.
All syringes and needles used in the course of preparation should be
placed in the puncture-proof container for disposal without being crushed, clipped or
Medical vials should not be vented unless a BSC is used as the work area or unless a
hydrophobic-filter needles unit is available to eliminate pressure. Syringe and needle
fitting should be of the Luer-lock variety.
- Diluent should be added slowly to the vial by alternately injecting small amounts,
allowing displaced air to escape into the syringe. (All the diluent should not be injected
at once; a large volume of displaced air will cause the syringe's plunger to back up and
possibly spray the drug or cause leakage around the needles.) When all diluent has been
added, a small amount of additional air may be withdrawn to create a negative pressure on
the vial, but this should not be expelled into room air because it may contain drug
residue. It should either be injected into a vacuum vial or remain in the syringe to be
A sterile gauze should be wrapped around the needles and vial top when
withdrawing solutions (Employees should take care to avoid needle sticks during this
procedure.). This drug should be withdrawn from the vial while negative pressure is
Any material remaining in the top of an ampule should be tapped down before it is opened.
A sterile gauze pad should be wrapped around the ampule neck before breaking the top to
protect against cuts and to catch aerosolized material.
- The ampule top should not be removed close to the employee's face. If diluent is to be
added, it should be injected slowly down the inside wall of the ampule. The ampule should
be tilted gently to ensure that all the powder is wet before agitating it to dissolve the
The needle should be held vertically with the needle upwards; the
syringe should be tapped to remove air bubbles and the air bubbles expelled into sterile
gauze, not into the air.
Personal Protective Equipment
Personnel administering CDs should wear:
- a gown as described in "Drug Preparation" (see Personal
- disposable surgical latex gloves--double if appropriate, and
a surgical mask also may be used.
It should be noted that this provides only minimal protection against CD
aerosols and is no substitute for the proper procedures, which have been described.
Disposal of materials or animals containing or
contaminated with cytotoxins or antineoplastic agents must be arranged through EHS.
Sealable plastic or wire tie bags of 4 mil thick polyethylene or 2 mil polypropylene,
labeled with a cytotoxic hazard label and colored differently from other trash bags,
should be used for the routine accumulation and collection of empty vials used containers,
syringes, discarded gloves, gowns, goggles and any other disposable material. All
CD-related wastes should be put into these bags, and nothing else.
Housekeeping personnel must wear gowns and surgical latex gloves when handling the waste
containers and should be instructed on the necessity of handling this waste with care and
on procedures governing spills and leaks. Contact the EHSO for disposal of these wastes.
Spills and breakages should be cleaned up immediately by a properly protected
person trained in the appropriate procedures. Refer to Section 1.3, "Biohazard Spills" for additional information.
Access to areas where CDs are stored should be limited to authorized personnel. Such areas
should be posted with a large warning sign, a list of all drugs covered by CD policies,
and a sign detailing spill procedures. Facilities used for storing CDs should not be used
for other drugs and should be designed to prevent containers from falling to the floor.
Warning labels should be applied to all CD containers, as well as the shelves and bins
where these containers are permanently stored.
Receiving Damaged CD Packages
Damaged cartons should be opened in an isolated area by an employee wearing the same
protective equipment that is used during preparation (including a PAPR) without a hood.
Within the facility, drugs should be securely capped or sealed and packaged in impervious
packing material for transport.
- Training of Personnel
All personnel involved in any aspect of the handling of CDs (shipment/receiving personnel,
physicians, nurses, pharmacists, housekeepers, or employees involved in the transport or
storage of drugs) must receive an orientation on CDs, including their known risks,
relevant techniques and procedures for their handling, the proper use of protective
equipment and materials, spill procedures, and medical policies. Prospective temporary and
permanent employees who will be required to work with CDs should receive notice of this
Evaluation of Staff Performance
Knowledge and competence of personnel should be evaluated after the first training session
and at least annually thereafter. Evaluation may involve direct observation of an
individual's performance on the job. Non-CD solutions may be used for evaluation of
preparation techniques. Quinine, which will fluoresce under ultraviolet light, provides an
easy mechanism for detection of clumsy technique.
All employees with potential exposure to CDs through
preparation, administration, housekeeping, waste disposal, transport or storage of CDs in
addition to being fully informed of all potential dangers and the need to take adequate
precautions, should have a baseline physical examination. Care should be taken to note any
risk factors in the history. A complete blood count including differential may be taken to
provide a baseline.
Annual medical monitoring should be performed under the recommendation of the University
occupational health service.
A registry of all staff who routinely prepare or administer CDs should be permanently
maintained, with the number recorded of each drug the employee has prepared or
administered if this is feasible. Please provide EHS with a copy of this registry and