Sterile Compounding Practice Labs

Practice Labs For The IV Certification Program


Before you start practicing, review the details listed below. These details will be important to keep in mind in the work environment. The list below is not all inclusive.

If you are new to sterile compounding always refer to the manufacturers package insert for important details regarding the drug you are compounding. Other factors to consider include.

Reconstitution
⁃ When reconstituting a powder vial make sure the diluent is compatible with the powdered drug in the vial.
⁃ Make sure the base solution such as sodium chloride or dextrose in which you will be injecting the reconstituted or non-reconstituted solution is compatible with the drug you are injecting.

Dilution of the compounded drug in a base solution

⁃ Ask yourself. What should the maximum concentration of the drug in the base solution be? For Vancomycin shown below the maximum concentration must be 5 mg/ml if diluting 500 mg in a base solution of sodium chloride, for example. So you would dilute the 500 mg in 100 ml of sodium chloride to achieve the concentration above. This is to prevent thrombophlebitis or inflammation and clotting in the vein.

Compatibility

⁃ Consider whether the drug you are compounding should be the only drug in a IV solution or can it be mixed with other drugs depending on what the physician has ordered. In other words, find out the IV compatibility of the compounded drug with the base solution and other drugs that may be injected into the same base solution (IV bag) if the physician order calls for it.

Single dose vs Multi-dose
⁃ Make sure you’re not drawing multiple doses out of single-dose vials which are included in the supplies.
⁃ A multi-dose vial which is bigger may be used to withdraw multiple doses.
⁃ Ensure you have the correct size syringe and correct size needle.
⁃ See below.


 

Instructions For Completing The Practice Labs

1. Complete ALL the practice labs shown below and read the instructions carefully.

  • Email me your answers for the practice labs including the final evaluation lab BUT DO NOT USE THE FINAL EVALUATION KIT. THAT KIT IS TO BE USED ONLY AT THE FINAL EVALUATION WHICH WILL BE SCHEDULED LATER.
  • Send me the documentation via email as a text attachment. So, you'll have to type the answers and attach it to an email and send it to me at mayur@ivcompoundingtraining.com 
  • Complete ALL the labs below using the supplies you received. Also, if you received a filter straw instead of a filter needle then draw the liquid from the ampule with the straw first and then remove, and secure a regular needle and inject into the appropriate bag.

2. Document your practice hours as shown below on this page

  • The practice hours must account for a minimum of 22 hours for Pharmacy Technicians and may include hours spent as part of your normal compounding duties at your place of employment.
  • The practice hours must account for a minimum of 2 hours for Pharmacists.
  • The practice kit(s) sent to you also contain the appropriate supplies to achieve the hours shown.
Name/ Title: Shelby W., Pharmacy Technician
Day & Date Activity Performed Number of Hours
Wednesday 07/20/2022 Hand Hygiene, Garbing, Practice Aseptic Technique by making Gentamicin Irrigation for bladder in IV room and practiced aseptic technique using ertapenem. 3
Thursday 07/21/22 Hand Hygiene, Garbing, Practice Aseptic Technique by making Vancomycin in Elastomeric Pump 3
Wednesday 07/27/22 Hand Hygiene, Garbing, Practice Aseptic Technique by making Vancomycin in Elastomeric Pump 3
Wednesday 07/27/22 Hand Hygiene, Garbing, Practice Aseptic Technique by making Gentamicin Irrigation for bladder in IV room. 3
Wednesday 08/10/22 Hand Hygiene, Garbing, Practice Aseptic Technique by making Gentamicin Irrigation for bladder in IV room. 3
Wednesday 08/17/22 Hand Hygiene, Garbing, Practice Aseptic Technique by making Gentamicin Irrigation for bladder in IV room. 3
Wednesday 08/24/2022 Hand Hygiene, Garbing, Practice Aseptic Technique by making Gentamicin Irrigation for bladder in IV room. 3
Wednesday 08/24/2022 Hand Hygiene, Garbing, Practice Aseptic Technique by making Ceftriaxone IV push in IV room 0.5

 

3. ANSWER THE QUESTIONS BELOW FOR EACH LAB AND THEN DOCUMENT THE ANSWERS AND PROCEDURE USING THE FORMAT SHOWN FURTHER BELOW.

 Ertapenem Lab

The physician wrote an order for Ertapenem 15mg/kg IV QD infused over 30 minutes X 7 Days to treat a patient’s skin Infection. Assuming the patient has normal renal function, weighs 140 lbs and is an adult.

*Round the weight in KG up or down to the nearest tenth when converting lbs to kg and answer the following questions.

1. What is the total prescribed dose?
2. How much of the Ertapenem is required daily?
3. How much of the Ertapenem is required per dose?

Hands-on Practice

**Look up dilution information for Ertapenem here: 

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=468105b9-48b3-4477-82c7-e7fb92460e28&type=display 

1. Calculate how much Ertapenem is required based on your answer for #3 above?
2. How much of the diluent is required to reconstitute the entire powder vial of Ertapenem?
3. What is the final concentration in the vial after reconstitution?
4. How much Ertapenem should be withdrawn and injected into the sodium chloride IV bag after reconstitution?
5. List the supplies and quantity (how many syringes, needles etc.) you will need to reconstitute the powder vial and draw out the appropriate volume and inject into the NaCl IV bag that is provided.
6. Document the entire compounding process including the steps required prior to compounding such as garbing process etc. steps required during and after compounding such as wiping the supplies before placing them in the hood, aseptic technique, cleaning the surface of the hood after completing compounding etc.

Vancomycin Lab

The physician wrote an initial order for Vancomycin 15mg/kg IV Q8H to be infused over 30 minutes and subsequent doses to be determined per pharmacy protocol to treat a patient’s MRSA (Methicillin Resistant Staphylococcus Aureus) infection.

Assuming the patient has normal renal function, weighs 70 lbs and is an adult.

*Round the weight in KG up or down to the nearest tenth when converting lbs to kg and answer the following questions.

1. What is the total prescribed dose?
2. How much of the Vancomycin is required initially?
3. How much of the Vancomycin is required per dose?

Hands-on Practice

*Look up the dilution information for Vancomycin (COPY & PASTE THE LINK IN A BROWSER IF LINK DOESNT WORK BY CLICKING ON IT) here: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060180s047lbl.pdf

1. Calculate how much Vancomycin is required based on your answer for #3 above.
2. How much of the diluent is required to reconstitute the entire powder vial of Vancomycin?
3. What is the final concentration in the vial after reconstitution?
4. How much Vancomycin should be withdrawn and injected into the sodium chloride IV bag after reconstitution?
5. List the supplies and quantity you will need to reconstitute the powder vial and draw out the appropriate volume and inject the volume into the IV bag that is provided.
6. Document the entire compounding process including the steps required prior to compounding such as garbing process etc. steps required during and after compounding such as wiping the supplies before placing them in the hood, aseptic technique, cleaning the surface of the hood after completing compounding etc. 

**The Tranexamic acid lab has been removed. IF YOU RECEIVED A KIT FOR IT PREVIOUSLY you can still practice with it using the same process as for the other labs and draw out 4.5 mLs and inject into the IV bag using aseptic technique.

 Ampule manipulation

For this lab you will be performing a straight draw from an ampule and draw out the entire contents of the ampule and inject into the IV bag.

1. List the supplies and quantity required to perform this manipulation.
2. Document the entire compounding process including the steps required prior to compounding such as garbing process etc. steps required during and after compounding such as wiping the supplies before placing them in the hood, aseptic technique, cleaning the surface of the hood after completing compounding etc.

Final Evaluation Lab - ONLY TO BE DEMONSTRATED IN FRONT OF THE INSTRUCTOR BUT THE ANSWERS MUST BE SENT TO ME PRIOR TO THE EVALUATION AS EXPLAINED ABOVE.

For this lab…

The physician ordered the following meds to be added to the 100 mL NaCl bag (or the TPN bag) if you received that instead.

⁃ 12mM of sodium phosphate (based on the phosphate content)
⁃ 500 mg calcium gluconate
⁃ 2 mL of trace elements from the ampule
⁃ 2 mL of the reconstituted powder solution IF you received a small powder vial OTHERWISE IF you received a 10 mL powder vial reconstitute it to a concentration of 300 mg/ml.

Based on the details above and the supplies provided for this lab… 
1. How many mLs of sodium phosphate are required?
2. How many mLs of calcium gluconate are required?
3. How much diluent is required to reconstitute the powder vial? This question applies if you received a 10 mL powder vial. If you received the small 2 mL powder vial then add 2 mLs of diluent to the powder vial.
4. What is the final concentration of the solution in the reconstituted vial? (will not apply if you received the small 2 mL powder vial)
5. List the supplies and quantity required to perform this manipulation.
6. Document the entire compounding process including the steps required prior to compounding such as garbing process etc. steps required during and after compounding such as wiping the supplies before placing them in the hood, aseptic technique, cleaning the surface of the hood after completing compounding etc.

 Example Of Correctly Documenting And Practicing The Labs Shown Above 

4. Use The Format Shown Below (type it once) FOR EACH LAB  & Complete Entirely Then Attach & Email It To Me Including The Hours Spent As Shown Above

Name: Jane Doe
Profession: Pharmacist OR Pharmacy Technician
Date: 3/23/23
Location: ____Center of Mckinney, TX


Ertapenem Lab 

Total Time Spent On The Lab: [insert hours]

Order for Ertapenem 15mg/kg IV QD infused over 30 minutes X7 days to treat skin infection. Assume patient has normal renal function and weighs 140 lbs.

Answers: (Enter the answer next to each question below)
1. Total prescribed dose? [Insert answer]
2. How much Ertapenem is required daily? [Insert answer]
3. How much Ertapenem is required per dose? [Insert answer]

            Hands-on Portion For The Ertapenem Lab
     (Enter the answer next to each question  below)

1. How much Ertapenem (in grams) is required based on your answer for #6 above? [Insert answer]
2. How much of the diluent is required to reconstitute the entire powder vial of Ertapenem? [Insert answer]
3. What is the final concentration in the vial after reconstitution? [Insert answer]
4. How many mLs of Ertapenem must be withdrawn from the vial based on your answer for #6 above and injected into the IV bag of sodium chloride after reconstitution? [Insert answer]
5. What is the final concentration of the solution after the reconstituted Ertapenem is injected into the IV bag of NaCl? [Insert answer]
6. List the supplies and quantity you will need to reconstitute the powder vial and draw out the appropriate volume and inject it into the NaCl IV bag. [Insert answer]

               Pharmacy & Ante Area Procedures

Pharmacy area prepping
  • Complete all calculations before starting compounding.
  • Gather all supplies and products needed.
  • Wipe down all containers and disinfect products before taking them into the buffer room for compounding.
  • Place the supplies in plastic totes or other approved containers and place them in the pass-through chamber to bring them directly into the buffer room or bring them into the buffer room through the ante room.
Ante area procedures
  • Put on shoe covers ( one foot at a time, and once the shoe cover is placed over one shoe, step over the line of demarcation).
[Complete the rest of the documentation]

                       Buffer Room Procedure

  • In the buffer room, pick the right size sterile gloves. Sanitize hands, wait for hands to dry then put on the gloves making sure not to touch the outside of the gloves. Some facilities require sterile gloving in the ante area. [Explain the gloving procedure]
  • Inspect gloves for holes, then spray the gloves with 70% Isopropyl sterile alcohol (IPA). Allow drying before cleaning the hood.
                    Hood Cleaning Procedures

[Explain the hood cleaning procedures for a vertical and a horizontal hood]
  • Place vials and all needed supplies 6 inches from the back and front of the hood, ensuring that the 0.9% NS bag port faces the HEPA filter (in a horizontal hood).
  • Place compounding supplies 2 inches apart to prevent air block. Place products wrapped in paper within the first 6 inches of the hood.
  • Remove the vial cover of the diluent and swab the rubber stopper.
[Complete the rest of the documentation for compounding ertapenem]

         Procedure After Compounding Is Complete

  • Rewipe the hoods compounding surface with sterile water and 70% IPA.
  • Put on a new pair of sterile gloves using the same procedure as above.
  • [Complete the rest of the documentation]

3. The example above isn't complete, it's to give you an overall picture of what needs to be documented. Document for each lab based on the questions for each lab and document the steps in detail that must occur. 

4. PRINT AND COMPLETE THE CHECKLISTS BELOW AND USE AS A GUIDE WHEN PRACTICING AND COMPLETING THE LABS. THE SAME CHECKLISTS WILL ALSO BE USED FOR THE FINAL EVALUATION SO THIS GIVES YOU AN IDEA OF WHAT YOU’LL BE EVALUATED ON.

 

 

Email me your answers for everything above and the documentation as explained above.