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VOLUME 4 NUMBER 3

Secundum
Artem Current & Practical Compounding
Information for the Pharmacist.

PHARMACY COMPOUNDING EQUIPMENT


Loyd V. Allen, Jr., Ph.D. pharmacists, it is important to know what
equipment is available, how to use and main-
INTRODUCTION tain it, and to be aware of changing
The “tools of the trade” for most professions responsibilities and opportunities in health-
have changed over the years. Physicians are care. As long as there is drug therapy, y,
therap
now using computers, laser light, high technol- pharmacists must be involved in the prepara- h e r e i s drug v e d i n
g as t invol
ogy communications systems and tion and/or provision and appropriate use of As lon s t s m u s t b e
a c i o r
biotechnology-derived drug products; lawyers the product to meet the specific needs of the pharm ration and/ ate use
r e p a o p ri
are extensively using computers and large patient. This is especially true for the newer the p appr
database search methods in the courtroom and and biotechnology-derived medications and v i s i o n and meet the
pro ct to t.
produ patien
pharmacists are using computers for such for providing patient-specific products which of the e e d s o f t h e
applications as dispensing, patient monitoring, must be compounded. ic n
specif
patient counseling, drug preparation activities, PURPOSE
high technology communications, access to The purpose of this issue of Secundem
data bases and drug delivery (pumps). Artem is to describe the different types of
As one observes the changes that have equipment and supplies that are now available
occurred over the past 25 years in the delivery for the compounding of drug products.
of medical and pharmaceutical care, it is evi- Obviously, this will not be a complete list as
dent that the equipment and supplies that are there are differences in practices of pharmacy
handled on a daily basis have changed. It is throughout the U.S. and many of these require
also notable that in many state boards of phar- different equipment and techniques. The intent
macy regulations, changes are being made to is to present the more common items and to
reflect current practice activities, especially as present novel uses for alternative equipment.
they apply to the preparation of drug products.
As one looks at change in pharmacy, it HISTORICAL REVIEW
becomes apparent that the rate of change is Historical records reveal that apothecaries
increasing, especially with new technology. began by using very simple equipment and
New methods and techniques must be learned tools. Common dosage forms included oint- ng
ecomi
and mastered as they replace older ones. ments, oils, powdered extracts from plants, etc.
a c i s t s are b l e v e l o f
Mortars and pestles were common, as were Pharm i n a h i g h e r
y.
However, many time-honored methods and ed armac
techniques are still valuable and appropriate knives and axes for obtaining the plants and i n v o l v y-based ph
lo g
today and should be maintained as long as plant parts. Other equipment included mixing techno
they are useful and contribute to patient thera- vessels and drying tables. Later, processes such
py. It is imperative, as one looks at current and as distillation and extraction were introduced,
future practice activities in pharmacy, to be resulting in more complex equipment require-
cognizant of the role that computerization and ments.
robotics play. These will impact counseling, Equipment used by pharmacists for com-
drug utilization review, medication manage- pounding during the 1940s, 1950s and 1960s
ment and dispensing activities. As was basic, consisting of mortars and pestles,
beakers, conical graduates, prescription bal-
Loyd V. Allen, Jr., Ph.D., Professor and Head, ances, hot plates, refrigerators, pill tiles and
Pharmaceutics, University of Oklahoma, HSC spatulas. During the 1970s, with the advent of
College of Pharmacy, Oklahoma City, OK 73190. pharmacist’s responsibility for intravenous
When swallowing a tablet is a problem... admixture services, additional equipment was introduced
into the pharmacy, including laminar flow hoods, aseptic
transfer devices/pumps and sterile filtration units.
In the 1980s and 1990s, the resurgence of compounding has
A Spoonful from resulted in a large increase in the diversity of equipment in
pharmacies, depending upon the scope of practice. From tra-
ditional compounding activities in the preparation of syrups,
suppositories, troches and ointments to the high-tech aseptic
Paddock Helps the compounding of total parenteral nutrition solutions contain-
ing 20 or more ingredients and even the programming of
ambulatory pumps capable of predetermined delivery of a
weeks supply of drugs contained in a small reservoir, phar-
Medicine Go Down macists are becoming involved in a higher level of
technology-based pharmacy.
Despite the tremendous changes in the equipment require-
ments of today’s practicing pharmacists, many regulatory
agencies have not “kept up with the profession” in updating
practice regulations. Since the practice of pharmacy is so
diverse, we have probably passed the time in which a Board-
defined single list of items will suffice for all practice settings;
rather, different lists must be developed dependent upon the
type of practice, i.e., community, hospital, home healthcare,
nuclear, traditional compounding and aseptic compounding.
Many regulatory bodies are now looking at this subject so we
will probably see increased activity in the future. Until that
time, this issue will serve as a reference for some of the equip-
ment and supplies that pharmacists are using, depending
upon their practice activities.
COMPOUNDING EQUIPMENT AND SUPPLIES
The approach taken in this presentation is to divide the
equipment into four areas of pharmacist involvement, as fol-
lows:
1. General nonsterile product compounding equipment
2. Advanced nonsterile product compounding equip-
ment
3. General sterile product compounding equipment
4. Advanced sterile product compounding equipment
The Paddock Solid-to-Liquid Solution The costs presented for some items are only approximate
and will vary greatly depending upon their source, quality
Paddock Laboratories is the leading pharmaceutical and design. Many routine items are simply listed without cost
supplier of compounding actives, and discussion, as use of these has become common.
vehicles and professional support. Discussion will usually be limited to those items for which the
applications and use may be unclear or for those in which
When compounding oral liquids, Paddock’s Ora-Plus® there is an unusual application. Many items are actually used
and Ora-Sweet® provide the solution. for both nonsterile and sterile product compounding.
NONSTERILE PRODUCT
Compounding with Confidence COMPOUNDING EQUIPMENT
General Nonsterile Product
Over 60 formulations extemporaneously compounded Compounding Equipment
with Ora-Plus® and Ora-Sweet® have been studied and tested. Balance—Prescription, Torsion
Balance—Triple Beam
These formulations and stability studies Beaker Hot Stand
provide you with an extra measure of confidence to Beaker Tongs
Beakers—50, 100, 150, 250, 400, 600,
“help the medicine go down”. 1000 mL Glass/Plastic/Stainless
For a copy of these stability studies, Steel
Beakers—With/Without Handles,
please call 1-800-328-5113 1000, 2000, 3000 mL Glass/
or visit www.paddocklabs.com. Plastic/Stainless Steel
Capsule Filling Equipment
Cylinders—Graduated 5 to 2000
mL—Glass/Plastic
Desiccators—Glass/Plastic
Desiccant (Drier-Rite®)
Dishes—Evaporating, Porcelain—
with/without Handles
Funnels—Glass/Plastic—2", 3", 4", Centrifuge Workbench protector sheets (plastic,
5", 6" Chopper/Grinder rubber, absorbable paper, matted)
Graduates—Pharmaceutical/ Coffee Grinder Wash Bottles
Conical 10, 25, 50, 100, 250, 500 Crimper, Hand operated Water system
and 1000 mL, Glass/Plastic Desiccator STERILE PRODUCT
Hotplates, Various Sizes and Desiccator/MicroMarinader COMPOUNDING EQUIPMENT
Features Creates vacuum. . . desiccator General Sterile Product
Glasses—Safety applications Compounding Equipment
Graters, Hand—Fine, Medium, Dispensing Pumps, Variable Speed Laminar Flow Hood, Horizontal
Coarse, Combination Pipet bulbs (Class 100)
Mortars/Pestles—Glass and Fat/oil separator (Gravy separator) Laminar Flow Hood, Vertical (Class
Porcelain—2, 4, 8 oz. Food Processor 100)
Openers—Jar/Bottle/Tube Slice, Grate, Chop, Puree, Mix, Refrigerator
Ovens—Drying Knead: various blades Anemometer, Direct Reading
Pill Tiles—Glass, Frosted Heat Gun, Variable Heat Outputs Ampule Openers, Disposable
Racks, Drying—Plastic or Epoxy Homogenizers, Hand operated Apparel for Clean Rooms (Class
Resin Material Lead Sticks, flexible 10,000)
Refrigerator with Freezer Light boxes Aprons, Sleeves, Gloves, Hoods—
Spatulas—4", 6"—Plastic and Magnetic Stirrers Open Face, Hoods—Face Mask,
Stainless Steel, Assorted Microspatulas, Stainless Steel, Teflon Boot Covers, Shoe Covers, Frocks,
Stir Plate—Magnetic with Stir Bars Coated Coveralls, Head Coverings, Lab
Stirring Rods Motorized Stirrer Coats, Smocks, Shirts/Pants, Hats/
Strainers—Small, Medium, Large Malt Shop Mixer (2 speed motor, Caps, Facemasks, Beard Covers
Suppository Molds (rectal, vaginal, stainless steel cup 28 oz.) Autoclave Tape
urethral) Mixer—Orbital, Single/Variable Biohazard Autoclave Bags
Thermometers—Glass Speed Biohazard Bag Holders
Thermometer Clips Mixer, Professional—Kitchen Autoclave Bags
Troche Molds Mortar/Pestle, wide shape Baggies/Pouches/Pouch Sealers
Weighing Dishes—Plastic and pH Meters, Variable Sizes/Styles Cleaning Materials
Aluminum Pipets, 1-100 mL Pickup Roller-Wall
Weighing Papers Pipet Fillers, Hand Operated Pickup Roller-Floor
Weight Sets Pipettors/Micropipettors—Variable Pickup Roller-Cabinet/Work
Size: 5-200 µL, 200-1000 µL Space
Advanced Nonsterile Product Pipettors—Multichannel Hazardous materials handling
Compounding Equipment Pipettor, Motorized equipment
(in addition to those listed above) Pitcher, Stirring Filter Units, Vacuum—Disposable
Balance, Electronic—Minimum 2000 mL capacity, Blades attached Filters, Sterilizing—Numerous types/
sensitivity of 10 mg. to handle, plastic shapes/applications
Balance, Electronic—Minimum Powder Blender Filter Unit—Repeating Syringe with
sensitivity of 1 mg. Blends powders in dust-free Three-Way connector and Check
Bath, Dry—Heater/Incubator environment and protects operator Valve
Beakers, Insulated from powder dust. Forceps
Beakers, Teflon Repeating Dispensers for Liquids Impulse or Induction Sealer for plastic
Beakers, Heat-resistant plastic Sealers, bag or suppository overwraps
Blender Sealers, tube Needle Destroyer
Liquefy, Puree, Mix Sieves, 3", 5", 7", various mesh sizes Pumps, Vacuum
12 mL to 4,000 mL capacities Solvent Dispensing/Spray Bottles Pump-Vacuum, Hand Operated
Temperature controlled, Foam Spatulas, Stainless Steel, Teflon- Pumps, Pressure
arrestor coated, Porcelain, Plastic. Refrigerator with Freezer
Blender, Hand—Variable speed Sprayer Bottles Sharps Disposal Unit
Mixing container, stand, various Tablet Press, single punch Stainless Steel Pressure Filter Holders—
blades, at least 2 speeds. Tea/Spice Ball Various Capacities
Blender, Hand—Two Speed Lab Thermometer, Hi-Lo Alarm Stainless Steel Pressure Vessels
Three blades, with stand Thermometer, Digital Probe Tacky Mats
Boiling Chips or Beads Thermometers with alarm Trash Container—Gowns/Apparel
Bottles, Drop Dispensing—Plastic or Test-tube rack, four-sided Articles
Glass Tongs, Beaker/Flask/Tube Trash Container—Plastic/Paper Articles
Bottles, Dispensing Fluid—Plastic or Tool Set, Cooks’ Wire Racks/Shelving
Glass Heavy gauge stainless steel
Brushes, Cleaning—Nylon—Various Pasta fork, turner, solid spoon, Advanced Sterile Product
sizes/shapes to fit equipment ladle, server, skimmer and hanging Compounding Equipment
Buckets with Lids—Plastic rack. (in addition to the above)
Burets, 10-50 mL Tubing, various sizes/types Autoclave
Burners, Bunsen or Similar (natural Tubing clamps, various sizes/types Filtration, Sterile—Equipment
gas or propane) Vortex Mixers Cooler/Heater for medication transport
Carboys with/without spigots Ultrasonic Cleaner, Various in automobile, 30 L
Carts, Plastic/Metal Capacities
Crimper, Hand Operated Advanced Nonsterile Product Compounding
Decappers Equipment
Ice Replacement Gel—Various Forms/Types Balances (electronic) ($850 to $2500) are available to
Osmometers weigh quantities as low as 1 mg. These electronic bal-
Particle Counter ances are useful in compounding pharmacies to weigh
Particulate Testing Equipment small quantities of drugs very accurately and with a rela-
Pump, Pressure—Vacuum tively low investment. They are easy to use, clean and
Pyrogen Test Materials calibrate. The cost of a balance is generally proportional
Quality Control Equipment to the lowest weight that can be measured.
Sample Transporter Coolant—Pouch Dry baths are alternatives to hot plates and are replac-
Maintains sample at about 50˚ F (below 10˚ C ing water baths in many laboratories. A dry bath is
for 30 minutes) essentially a heated chamber that can be filled with sand,
Smoke Sticks salt or aluminum blocks designed to hold various sizes of
Spatulas and Spoons, Sterile—Plastic for weighing glassware. For example, a beaker can be “wiggled” into
and obtaining drugs the sand after the sand has equilibrated to the desired
Sterility Test Equipment temperature for heating a preparation. These dry baths
Ultra-Freezer (Capable of about -80˚ C) are easy to use and clean and are virtually maintenance-
free.
DISCUSSION
Blenders (Cabinet top and hand held, $50-$300) are
General Nonsterile Product Compounding
indispensable in the preparation of many products.
Equipment
Kitchen blenders are excellent for preparing solutions,
Beaker Hot Stand is a rubber or plastic molded hand
suspensions, emulsions and even gels (if done properly).
protector that is convenient for picking up hot or very
They are available in the standard kitchen size of about 28
cold beakers, flasks, etc.
ounces and in laboratory sizes with vessels ranging from
Capsule Filling Devices are available in numerous for-
12 mL to about 4,000 mL. Hand-held blenders are excel-
mats. From inexpensive plastic units ($20) for 25 or 50
lent for preparing lotions, creams and other semisolid
capsules to the more rugged 100-capsule machines ($500-
and liquid preparations. They are available as single,
$1500), these are timesavers if a large number of capsules
dual and variable speed.
is being prepared. The 100-capsule units can be used for
Carts (plastic/metal-$50-300) are items of equipment
preparing smaller numbers and work well with locking
or furniture that can be very useful in compounding.
capsules.
They can serve to move supplies from one area to anoth-
Desiccators ($50-100) containing a desiccant are
er as well as provide working surfaces when necessary.
important for storing drug products that require a very
Choppers/Grinders ($30) and Coffee Grinders ($15-
dry atmosphere. Desiccators are available in glass or
25) are available in kitchen departments in large stores as
plastic and may have a port for a vacuum.
well as in gourmet shops. They can be used for particle
Glass Pill Tiles ($35) customarily are used for the
size reduction and even for blending small quantities of
preparation of many different dosage forms. Many come
powders.
with graduated markings on one end for measuring
Crimper, hand operated ($250) is used to attach alu-
lengths of suppositories, pill pipes, etc. Most glass pill
minum tamper-evident safety caps on containers of
tiles also have a “frosted” portion which is to be used as
prepared products. This is a very convenient system for
the primary work area. This area also provides a good
packaging products where evidence of the package hav-
working surface for comminution with a stainless steel
ing been opened is desired and is similar to the seals used
spatula, and for mixing ointments.
Ovens-Drying ($600-1000) are often required for the for injectables.
drying of various compounded products and for the dry- Dispensing pumps, (variable speed, $1500-2000) are
ing of products that might have adsorbed or absorbed invaluable when the same volume of a liquid has to be
moisture over time. As the potency of drugs increases, measured and dispensed repeatedly. They are especially
the sorption of moisture will become even more danger- useful in packaging finished products into containers.
ous due to weighing errors which may occur if the drug Pipet bulbs ($10) can be used to aid in pipetting and
is not dried before weighing due to the apparently eliminate many of the dangers associated with pipetting
greater weight of the material. by mouth. There are numerous styles of these bulbs
Stir plates (magnetic with stir bars) are becoming com- which may be used not only with measuring pipets but
monplace in pharmacies involved in compounding a also with transfer pipets for moving small quantities of
large number of fluid preparations. This frees up phar- liquids from one vessel to another.
macists time to do other duties while ingredients are Fat/oil separators ($10) can be used to obtain a foam-
dissolving and mixing. If the plate has a heating element, free liquid from an ingredient that has a foam on top
melted ointments and suppository bases will be more which makes it difficult to measure. The spout originates
easily mixed to uniformity. at the bottom of the container so the liquid, not the foam,
Suppository and Troche molds made of plastic are is dispensed. These are often referred to as “gravy sepa-
slowly replacing the older heavy metal molds. The molds rators”.
may also serve as part of the dispensing package. Caution Food Processors ($200) capable of slicing, grating,
must be observed since these molds are available in dif- chopping, pureeing, mixing and kneading, depending
ferent sizes, unlike many of the metal molds which were upon the various blades that are available, have many
reasonably standardized at 2 mL each.
applications, including the preparation of ointments and
Weight sets (Brass, $75) usually contain both apothe-
cary and metric weights for use with prescription pastes.
balances. The metric system is now the only official sys- Heat guns (variable heat, $50-65) can be used when
tem in the U.S.P. XXIII. heat is required in a situation where a hot plate is incon-
venient. A heat gun can be used to direct the heat to a
specific area where it is needed, as in sealing plastic dose active drug and excipients can be weighed and placed in
containers. It can also be used to apply gentle heat to the die, the handle lowered, and a tablet produced by
beakers of liquids, etc. compression.
Homogenizers (Hand operated, $375) are available for Tea/spice balls ($5-15) can be used to contain a flavor-
assistance in the preparation of fine emulsions. They are ing ingredient while immersing it in a liquid until the
easily disassembled for cleaning and work with as little desired strength is obtained.
as 60 mL. of liquid. Thermometers with alarm ($60) can be used to pro-
Lead Sticks (Flexible) are convenient for wrapping vide an audible indication when a refrigerator or oven
around beakers, flasks, and other pieces of equipment to gets out of a preset temperature range. These are most
prevent them from falling over. The sticks are made of often used on freezers and refrigerators, especially ultra-
soft lead with colorful plastic coatings and are available freezers.
in many diameters and lengths. They easily may be Tool sets, cooks’ ($50) have some useful implements
shaped or formed to fit around almost any piece of labo- for compounding, often including a pasta fork, turner,
ratory glassware or equipment. solid spoon, ladle, server and a skimmer; complete with
Light boxes are excellent aids to determining the com- a hanging rack.
pleteness of solution when dissolving solids and for Ultrasonic cleaners, ($175-1000) are useful for cleaning
detecting precipitants when working with materials that items but are also very useful for accelerating the disso-
may be incompatible or near the limit of solubility. A sim- lution of slowly dissolving drugs.
ilar piece of equipment can be made by painting a piece Water system (high quality, various prices) may be
of Masonite one-half black and one-half white, using required if the Pharmacy is involved in preparing a large
“flat” paints. When this board is hung on a wall with a quantity of products requiring different grades of water.
fluorescent light immediately above it, the dark and light Workbench protector sheets of plastic, rubber or
backgrounds may be used to help determine the presence absorbable paper are often convenient for defining a
of particles in a solution. work area for a specific project. They can be cleaned or
Orbital mixers ($300) can be used to mix a large num- disposed of when finished.
ber of beakers, bottles, flasks, etc. simultaneously. The
containers are fixed in place on a platform that moves in General and Advanced Sterile Product
a circular or orbital motion. These are very widely used Compounding Equipment
in laboratories and can be used to advantage in com- Many of the items listed in the categories of sterile
pounding pharmacies where a large number of product compounding and advanced sterile product
containers need to be mixed simultaneously. compounding can be placed into one of four general cat-
Mixer (professional or kitchen, $350-450) can be used egories. The first group includes those items that are used
for beating, mixing, whipping and kneading with flat for the preparation of sterile products: ampule openers,
beaters, dough hooks and wire whips. They can be used impulse sealers, vacuum pumps, sterile filtration equip-
for the preparation of products ranging from liquids, ment, sterile spatulas and spoons. Second is a list of items
including emulsions, to ointments. for quality control, including an anemometer, particle
pH Meters ($50-2000) are now commonplace in com- counter, particulate testing equipment, pyrogen test
pounding pharmacies. pH is critical for drug solubility materials and sterility test equipment. The third area is
and stability. Many products must be buffered, or the pH that of product storage and delivery, including such
adjusted to a certain range that requires a greater degree items as a refrigerator, cooler/heater for automobile, ice
of accuracy today than that provided by pH indicator replacement gel, and an ultra-freezer. Fourth, we include
papers. those items used for maintenance of the clean room envi-
Pipettors (micropipettors-variable sizes 5-200 µL, 200- ronment, such as apparel for personnel, cleaning
1000 µL, $175 each) are excellent for measuring small materials, and HEPA filters.
volumes of liquids accurately. They eliminate the need to
SUMMARY
prepare aliquots of drugs where only a very small quan-
To invest or not to invest? This is an age-old question
tity is required. Variable micropipettors are available so
concerning business opportunities, both professional and
the investment can be kept to a minimum. For example,
vocational. Some pharmacists hesitate to invest hundreds
one micropipettor can be used for 200 to 1000 uL and
or thousands of dollars in equipment necessary to
another one for 5 to 200 uL. Multiple channel micropipet-
become involved in compounding pharmacy. There is no
tors are available for use where up to 12 channels must be
question that taking the time and using the professional
delivered simultaneously; for example, when 0.5 mL is
and scientific expertise of the Pharmacist in preparing
being placed in small vials/ampules and a large quantity
specific dosage forms and strengths to meet the individ-
are being prepared.
ual needs of patients is financially worthwhile. A first
Powder blenders ($2000-4000) enable pharmacists to
step includes informing local Physicians of the availabili-
blend powders in a dust free environment and protect the
ty of compounding services to meet the needs of their
operator from powder dust. These blenders mechanical-
patients and practice. This brief introduction often has
ly blend in enclosed plastic bags without allowing any of
resulted in new opportunities for professional activities.
the powder to escape into the environment.
In times of shrinking fees and margins and increased
Sealers, bag or suppository ($115) are convenient for
demands on pharmacists time for patient counseling,
sealing plastic bags or certain suppository molds.
investments in time-saving technologies should be con-
Sealers, tube ($800) are widely used for packaging
sidered, as should additional services to meet the
large numbers of ointments, creams, or gels in plastic
demands of the marketplace for individualized patient
tubes. They are easy to use and provide reproducible
care through compounded prescriptions.
results attractively packaged.
Tablet press (single punch, $550) is an easy-to-use
method of preparing individual tablets. A blend of the
Compounding Actives Compounding Vehicles
for
l
l
Hydrocortisone Topicals
l Progesterone l Suppositories
l Morphine Sulfate CII l Suspensions
l Syrups
1-800-328-5113
and other chemicals actives available all
guaranteed to meet or exceed USP standards. You can rely on Paddock Laboratories www.paddocklabs.com
for compounding actives, vehicles and
compounding information.

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