10/15/2018 1 Review of Sterile Compounding per USP 797 and Related Pharmaceutical Calculations MICHAELA M. ALMGREN, PHARMD, MS OCTOBER 17 TH , 2018 Disclosure The author has no conflict of interests that need to be disclosed. Objectives 1. Examine importance of sterility when utilizing aseptic technique to prepare IV products and the role of USP Chapter 797 in maintaining infection control of IV products. 2. Identify key elements of USP 797 with focus on sterile compounding processes performed by pharmacy technicians. 3. Discuss correct sterile compounding equipment selection practices. 4. Review proper compounding technique and pharmaceutical calculations used in IV product preparation when reconstituting dry lyophilized drug powders. 5. Solve other relevant pharmaceutical calculations in parenteral product preparation. Pre-test Question #1 True or False? Term “sterile” is defined as free from bacteria and other living microorganisms and it is not a relative term. A. True B. False
Transcript
10/15/2018
1
Review of Sterile Compounding per USP 797 and Related Pharmaceutical CalculationsMICHAELA M. ALMGREN, PHARMD, MS
OCTOBER 17TH, 2018
DisclosureThe author has no conflict of interests that need to be disclosed.
Objectives1. Examine importance of sterility when utilizing aseptic technique to
prepare IV products and the role of USP Chapter 797 in maintaining infection control of IV products.
2. Identify key elements of USP 797 with focus on sterile compounding processes performed by pharmacy technicians.
4. Review proper compounding technique and pharmaceutical calculations used in IV product preparation when reconstituting dry lyophilized drug powders.
5. Solve other relevant pharmaceutical calculations in parenteral product preparation.
Pre-test Question #1True or False?
Term “sterile” is defined as free from bacteria and other living microorganisms and it is not a relative term.
A. True
B. False
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Pre-test Question #2USP Chapter 797 is enforceable by:
A. FDA
B. USP
C. State Board of Pharmacy
D. All of the above
Pre-test Question #3What is the purpose of Glove Fingertip Testing?
A. To assess whether the personnel can perform hand washing correctly.
B. To assess whether the personnel can clean the working surfaces correctly.
C. To assess whether the personnel can gown correctly.
D. To assess whether the personnel can perform hand hygiene and don on sterile gloves correctly.
Pre-test Question #4Size of the needle is defined by the length and gauge. When you are selecting a needle in preparation for sterile compounding, the ____________ is the number indicating the gauge of the needle, the _____________ is the lumen of the needle.
A. higher, smaller
B. higher, larger
C. lower, smaller
D. Lumen is always the same size https://www.sigmaaldrich.com/analytical-chromatography/syringes/learning-center/selection-guide.html
Pre-test Question #5If by adding 4 mL of SWFI to 5g of lyophilized powder we achieve concentration of 1 gram/mL and the powder volume is 1mL, then by adding __ mL we get the concentration of 500 mg/mL.
A. 10 mL
B. 9 mL
C. 8 mL
D. 5 mL
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Pre-test Question #6How many grams of dextrose are in 500 mL of 50% dextrose solution?
A. 500 g
B. 250 g
C. 100 g
D. Cannot be determined based on the information given.
Pharmacy Compounding Definitions
Compounding of medications--fundamental part of pharmacy practice
FDA definition: a practice in which a licensed pharmacist, a licensed physician, or a person under the supervision of a licensed pharmacist combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient not otherwise commercially available.https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacyco
•To customize medication for patient needs based on their size/age/labs, etc.
•Typically using sterile materials and environment
Exception: High Risk Sterile Compounding- sterile products compounded from non-sterile ingredients and/or compounded using any non-sterile devices, containers, or equipment
Sterility is EXTREMELY IMPORTANT as contaminations may lead to severe patient harm
Natural body's defenses are bypassed by parenteral introduction
As number of manipulations increase, so does the risk of contamination http://epmonthly.com/article/the-right-route/
Sources of Contamination of Sterile Products
Operator/Compounder◦ Touch (contamination of critical sites)◦ Poor handwashing/gloving practices◦ Improper compounding technique◦ Lack of trainingEquipment◦ Use of inappropriate equipment ◦ Packaging issuesSupplies◦ Contaminated supplies◦ Incorrect use of multi-dose containers
Purpose of USP Chapter 797To provide guidelines to prevent harm, including death, to patient (human or veterinary) that may be caused by:◦ contamination◦ improper compounding technique
Considered minimum practices and standards
Control of compounding personnel, environment and processes
United States PharmacopeiaScientific non-profit, non-governmental organization
Provides definitions, descriptions, guidelines and requirements for multiple pharmaceutical settings
Chapters <1> to <999> are considered enforceable by FDA
Over <1000> are considered guidelines
Chapter <797> introduced in 2004 Relates to requirements for sterile compounding
Revised standard released in 2007 Became official in 2008
Used to adjust concentration from one strength to another, typically by dilution.
Example in practice: preparing normal saline (0.9% NaCl) from concentrated (23.4% NaCl) solution.
Example: How much 23.4% NaCl do you need to add to make 250 mL of NS?
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SolutionSet up your equation: V1 x C1 = V2 x C2
23.4% x C1 = 0.9 % x 250 mL
Solve for C1: C1 = 9.6 mL
Important: Remember that the concentration can also be expressed in other ways such as mg/mL, mEq/L, etc.
Now you try it!
You need to prepare 100 mL of 5% dextrose (D5W). You have 50% dextrose solution available. How many mLs should you use?
Dry Powder Reconstitution Used to calculation how much solvent to add to reconstitute the drug to given concentration.
Example in practice: Commonly seen on antibiotics packaging.
Example: If by adding 4 mL of SWFI to 5g of lyophilized powder we achieve concentration of 1 gram/mL and the powder volume is 1mL, then by adding __ mL we get the concentration of 500 mg/mL.
Solution: ?
SolutionExample: If by adding 4 mL of SWFI to 5g of lyophilized powder we achieve concentration of 1 gram/mL and the powder volume is 1mL, then by adding __ mL we get the concentration of 500 mg/mL.
Solution:
Step 1: Determine the initial final volume. Hint: if powder volume is mentioned, most likely need to be accounted for.
4mL of diluent is added to 1 mL of powder, thus now 5 mL of volume.
Step 2: Set up V1xC1=V2xC2 formula Note: make sure all units match!!!!
(1g/mL) x 5mL = (0.5g/mL) x X mL
Solve for X: 10 mL
Step 3: Distract powder volume from total volume calculated.
Correct answer: 9 mL
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Another SolutionExample: If by adding 4 mL of SWFI to 5g of lyophilized powder we achieve concentration of 1 gram/mL and the powder volume is 1mL, then by adding __ mL we get the concentration of 500 mg/mL.
Solution:
Step 1: Set up dimensional analysis
5 grams = 0.5 grams
XmL 1 mL
Solve for X Hint: if powder volume is mentioned, most likely need to be accounted for.
Step 2: Distract powder volume from total volume calculated.
Correct answer: 9 mL
Now you try it!
The label on a vial reads: “Add 9.2 mL of diluent to get 10 mL of 100 mg /mL solution for injection.” The vial contains 1 g of drug. How many mLs of diluent should you add to make the final concentration 250 mg/mL?
% weight in weight means grams per 200 mL Use: preparation of solutions using dry powder in solvent
Commonly used in sterile compounding (% w/v)
% volume in volume means volume per 100 mL
Use: preparation of solutions using other solutions
(% v/v)
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ExampleHow many grams of dextrose are in 500 mL of 50% dextrose solution?
Solution
Example: How many grams of dextrose are in 500 mL of 50% dextrose solution?
Solution:
50% dextrose means 50 grams in 100 mL
Set up ratio proportion:
50g = X g
100mL 500 mL
Solve for X: 250 g
Now you try it!How many liters of a 0.9% aqueous solution can be made from 18.0g of sodium chloride?
Post-test Question #1True or False?
Term “sterile” is defined as free from bacteria and other living microorganisms and it is not a relativeterm.
A. True
B. False
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Post-test Question #2USP Chapter 797 is enforceable by:A. FDAB. USPC. State Board of PharmacyD. All of the above
Post-test Question #3What is the purpose of sterile fingertip testing?A. to test the operators if they can perform hand washing correctlyB. To test the operators if they can clean the working surfaces correctlyC. To test the operators to see if they can gown correctlyD. To test the operators to see if they can don on sterile gloves correctly.
Post-test Question #4Size of the needle is determined by the length and gauge. When you are selecting a needle in preparation for sterile compounding, the ____________ is the number on the package indicating the gauge of the needle, the _____________ is the lumen of the needle.
A. higher, smaller
B. Higher, larger
C. Lower, larger
D. Lower, smaller
Post-test Question #5If by adding 4 mL of SWFI to 5g of lyophilized powder we achieve concentration of 1 gram/mL and the powder volume is 1mL, then by adding __ mL we get the concentration of 500 mg/mL.
A. 10 mL
B. 9 mL
C. 8 mL
D. 5 mL
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Post-test Question #6How many grams of dextrose are in 500 mL of 50% dextrose solution?
A. 500 g
B. 250 g
C. 100 g
D. Cannot be determined based on the information given.
Questions?
ReferencesUSP Chapter 797 from USP 40, NF 35 official until May 1st, 2018
Proposed USP Chapter 797 published September 25th 2015
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