sterile
environment
institutional pharmacy--- 18% of CPhT workers.
works with nursing home, hospital,
long term care, hospice patient. they do sterile and nonsterile
compounding. oral meds are given unit dose(individual package
by factory or pharmacy). No fake nails allowed.
•parenteral---(not rectal or in mouth)body cannot get the chance to
‘evaluate’ the drug and screen out contaminates.
•aseptic technique ---keeping sterility to protect drug from
contamination
•greatest source of contamination is….you! person working on the
product.
•syringe---length, inches of needle.
•gauge----bigger number=smaller needle
•Extemporaneous=nonsterile
•Viscosity=thickness/flowing of a liquid
•Analytical balance=digital readout balance
IV push--syringe into vein
NPO---pt gets nothing by mouth
CSP---compounded sterile preparations
LR---lactated Ringer’s solution
Bolus=amount of drug in ‘one shot’
You can have about 10% error---(Amt of error/needed amount)X100=% error
Need 50g but got 50.74g
.74g/50gx100=1.48% off request
unit dose
Precipitation=solid particles appear
In a clear solution
Aseptic tech certification—written test and
Media-fill test(bacteria test)
must have name, dose, lot number, expiration, NDC number
Most common solvents for IV rx
NS= normal saline=.9%nacl
½ ns=.45% nacl
D5W=dextrose in 5% water
LR=lacrated Ringers solution
SWFI=sterile water
PCA=pt controlled analgesia
Multidose vials(MDV) will have preservatives. Good for 28 days.
Single dose vials(SDV) have no preservatives. Use immediately!
Nonsterile compounding for emergency=use immediately
Low risk contaminants---48 hr room temp 14day=refrig
Med risk=room temp=30hrs refrig=7 days
High risk—room temp=24hr refrig=3days
Chemotherapy technique use vertical flowhood.
TPN has 1—amino acids 2---lipdis 3—dextrose 4—sterile water
Plus maybe electrolytes, elements, minerals, drugs
Hyperameliation=TPN
sterile environment
big needle has small gauge
luerlok--screw on needle
sterile environment
• rubber stopper on bottle---insert need 45deg to
avoid coring.
• laminar flow hood---blows filtered air across
work area.
• HEPA filter---High Effiency Particulate Air
filter.catches particles and organisms to .3
microns. removes 99.997% of contaminants.
• old flow hoods were horizontal, wind blows at
operator. vertical flow blows air downward.
sterile environment
• In 2012---200 pt get fungal meningitis from poor
practices
• USP sets standards for production of
medications
• USP 797----chapter 797 covers equipment,
technique, and quality control for sterile
products.
• USP 795--chapter 795 covers nonsterile
compounder responsibility=‘pills,powder’
• sterile=parenteral=USP797
sterile environment-USP ch 795
USP <795> outlines the responsibilities of the compounder,
which can be summarized as being responsible for compounding
preparations of acceptable strength, quality, and purity with appropriate packaging
and labeling in compliance with requirements established by applicable laws and
agencies (eg, state boards of pharmacy). Specifically, the responsibilities of the
compounder include the following general principles:
Personnel are capable and qualified to perform their assigned duties.
Compounding ingredients of the appropriate identity, quality, and purity
are purchased from reliable sources.
All equipment used in compounding is clean, properly maintained, an
used appropriately.
Only authorized personnel are allowed in the immediate vicinity of the
drug compounding operations.
There is assurance that processes are always carried out as intended or
specified and are reproducible.
The compounding environment is suitable for its intended purpose and to
prevent errors.
Adequate procedures and records exist for investigating and correcting
failures or problems in compounding, in testing, or in the
preparation itself.
sterile environment-usp 797
“THE INTENT OF <797> IS TO PREVENT HARM
AND FATALITY TO PATIENTS THAT COULD
RESULT FROM MICROBIAL CONTAMINATION
(NONSTERILITY), EXCESSIVE BACTERIAL
ENDOTOXINS, LARGE CONTENT ERRORS IN
THE STRENGTH OF CORRECT INGREDIENTS,
AND INCORRECT INGREDIENTS IN
COMPOUNDED STERILE PRODUCTS (CSPs).”
or..is your workplace clean enough? furniture, ceiling,shoe covers
gowns, washing, gloves, hair cover..PPE
1---responsibilities
2—verify accuracy
3---training
sterile environment
• CSP---compounded sterile products
• Clean room—has flow hood, HEPA, approved
personnel only. Positive pressure room
• Anteroom---has supplies, sink
ISO standards-----International Organization for
Standards
• ISO number is particles in cubic meter of air.
• USP 797 wants ISO class 5 in the laminar hood
• class 7 in clean room
• class 8 in anteroom
ISO chart
outside air has about 35million particles/ccm that are bigger
than .5micron
single dose vial----one time use for compounding
multi dose vial---several uses
ampule---single use medication in glass vial,
break glass, use filter needle
IV push---IV meds delivered at one time by needle
continuous infusion----several hours delivery
IV piggyback---additional med that hooks into main bag
TPN--total parenteral nutrition into subclavian
protein, carbs, fats, electrolytes by IV
PPN-peripheral parenteral nutrition by arm/legs
NS--normal saline--.9%NaCl
1/2NS--.45%NaCl
D5W---5% dextrose in water
biohazard container-- anything that touches
chemo meds or IV antibiotics
sharps container--for glass and needles
media fill test---use broth instead of drug to discover
any bacterial growth. 35c for 14 days.
clean room video--https://www.youtube.com/watch?v=x440QBi_xfQ
clean the BSC--https://www.youtube.com/watch?v=dcGjVs5jLvA
airflow in hood---https://www.youtube.com/watch?v=Wg61LdngWlQ
clean laminar flow hood-https://www.youtube.com/watch?v=rvz_MRM2ZvI
aseptic handling-https://www.youtube.com/watch?v=VSSXGD79T8U
Antineoplastic technique
https://youtu.be/px1hzFO5kcM