Personnel Training and Evaluation
Sterile Non-Hazardous Compounding <797>

Purpose/ Applicability:  To ensure that all personnel who prepare CSPs are trained conscientiously and skillfully by expert personnel and meet the minimum requirements for being involved in the aseptic compounding process.

Scope: Training requirements are applicable to anyone preparing CSPs.

 

Definition(s):

USP : United States Pharmacopeia

CSP : Compounded Sterile Product

PPE : Personal Protective Equipment

ASHP : American Society of Health-System Pharmacists

Equipment:

ASHP Healthcare Video and Book

QI Medical Aseptic Media Fill Kit + Associated Materials

Chemoteq Aseptic Media Fill Kit + Associated Materials

Required PPE

Agar Plates for Fingertip Testing

Procedure:

Personnel Training:

• Personnel who prepare CSPs must perform didactic review, pass a written examination and successfully complete media fill testing of aseptic manipulation
  • Written examination and didactic review must be completed annually
  • Media fill testing must be completed:
    • Annually if compounding low risk and medium risk preparations
    • Every 6 months if compounding high risk preparations
• Any personnel who fail written tests or media fill tests should be immediately reinstructed and reevaluated to ensure correction of any deficiencies

Didactic Review

• Complete by watching ASHP Healthcare Standards video and/or reading the associated textbook
• Review how to properly garb and gown for both non-hazardous and hazardous rooms
• Demonstrate ability to put on sterile gloves appropriately

Written Examination

• Written examination developed based on the ASHP Healthcare Standards video and book
• Must pass with at least an 80% 
  

Media Fill Testing

• Complete per guidelines for non-hazardous and hazardous rooms – used to assess quality of aseptic skill of compounding personnel
• QI Medical kit is used for aseptic non-hazardous and Chemo-TEQ kit is used for aseptic hazardous. Processes and procedures are below.

 

Certification Overview

1. Watch ASHP Video Guide to Chapter <797> (60 minutes)
2. Complete quiz and pass with 80% or higher
   1. Get quiz from Alex and return for grading
3. Complete correct garbing procedure
   1. Follow procedure as attached
4. Complete glove fingertip testing
   1. Following gowning procedure through to putting on sterile gloves then stop and complete testing
      1. Press fingertips of 4 fingers and then thumb against agar plate
         1. Repeat with other hand
      2. Make sure plates are labeled with name, L/R hand, and first gloved test
   2. Remove gloves and put on new pair
   3. While completing media fill process (after using alcohol and entering the hood)
      1. Press fingertips of 4 fingers and then thumb against agar plate
         1. Repeat with other hand
      2. Make sure plates are labeled with name, L/R hand, and second gloved test
5. Complete media fill testing
   1. Follow instructions as attached
6. Complete CHEMOTEQ certification
   1. Follow instructions as attached
7. **Check glove fingerprint tests, media fill bags, and CHEMOTEQ bags after appropriate incubation periods to determine pass / fail 

 

 

Non-Hazardous Clean Room Certification Process

Supplies Needed:

 

Low/Medium Risk Preparation

4   Contact plates 1   GroMed ampule GroMed partially filled minibag GroMed 20 mL vial

3 mL syringe 1   Filter needle 21 18G x 1” needles Alcohol swabs

 

 

 

High Risk Preparation

Nonsterile compounding room
3gm packet of soybean-casein digest broth 100 mL vial of sterile water 100 mL sterile vial	60 mL syringe 1   18G x 1” needle  Alcohol swabs

 

Sterile compounding room
1   100 mL vial of dissolved soybean broth 0.2 microliter syringe filter 1    20 mL syringe	18G x 1” needle Alcohol swabs

*Prior to going into clean room, the 3gm packet of soybean-casein digest broth must be dissolved in 100 mL of sterile water via heating and stirring. Dissolved broth can be brought into clean room in 100 mL sterile vial. (Can split up between vials if completing multiple tests)

 

Garbing Procedure, Fingertip Test, Cleaning Hood

Completed	Procedure	Comments
	Remove jewelry / outerwear
	Put on shoe covers / cleanroom shoes
	Puts on appropriate mask
	Puts on bouffant
	Wash hands and forearms for at least 30 seconds
	Dry hands with lint free wipes
	Put on gown and boots
	Disinfect hands with sterile alcohol
	Put on sterile gloves appropriately (do not touch anything after putting gloves on)
Complete gloved fingerprint test #1

 

Completed	Procedure	Comments
	Press fingertips of 4 fingers and thumb of left hand against agar plate
	Repeat with right hand
	Discard sterile gloves
	Disinfect hands with sterile alcohol
	Put on sterile gloves appropriately
Enter nonhazardous side of cleanroom

 

Completed	Procedure	Comments
	Clean hood properly with sterile alcohol (top to bottom, back to front)
	Clean IV pole properly with sterile alcohol
	Spray each component prior to placing it in the hood
	Spray gloves before entering the hood
	If the hood is left for any reason, gloves need to be sprayed with alcohol before re-entering

 

 

Completion of Media Fill

Low/Medium Risk Preparation

Completed	Procedure	Comments
	Grab components for both preparations, spray them with alcohol, and enter the hood
	Ensure all products are at least 6 inches in the hood and all preparations are completed at least 6 inches in the hood
	Wipe the vial, and all injection ports of the bag with alcohol
	Using an 18G needles and 3 mL syringes, withdraw 1 mL from the vial and inject it into the bag
Complete gloved fingertip test #2
	Press fingertips of 4 fingers and thumb of left hand against agar plate
	Repeat with right hand
	Discard sterile gloves
	Disinfect hands with sterile alcohol
	Put on sterile gloves appropriately
Finish low/medium risk preparation
	Change the needle and repeat the process for each of the remaining 19 needles using the same syringe
	Final transfer should empty contents of the vial

 

High Risk Preparation

Completed	Procedure	Comments
	Followed all instructions as previously described on first page to prepare the soybean broth and transfer the contents into a 100 mL sterile vial for the preparation
	Wipe down vial top and port of bag with alcohol swabs
	Using an 18G needle and 20 mL syringe, draw out 10 mL of the nonsterile product
	Remove the needle and attach a 0.2 microliter filter and new needle to the syringe
	Inject 10 mL of the sterilized product into the bag from the low/medium risk preparation

 

Cleaning and De-garbing

Completed	Procedure	Comments
	Dispose of syringes and sharps in the appropriate container
	Throw away plastic and wrappers in trash can
	Clean hood properly with sterile alcohol (top to bottom, back to front)
	Clean IV pole properly with sterile alcohol
	De-garb in the anteroom appropriately

 

 

Once out of the cleanroom – (For Pharmacist)

• Label the final bag
• Immediately inspect bag for particulates, coring, fibers
  • Nothing should be present in the bag and if it is then it should be recorded as to not be mistaken with microbial growth later on
• Incubate at room temperature for 14 days
• Examine daily for turbidity
  • If turbidity is observed, growth from microorganisms is indicated and the test is positive
  • If the bag is clear, the test is negative and the operator has passed the test

 

 

Supervisor acknowledgement of no growth after 2 weeks:

 

Signature: _______________________________________    Date: ____________________

 

 

Gloved fingertip test – (For Pharmacist)

• Incubate at room temperature for 14 days
• Examine daily for growth
  • If growth is observed, test is positive and operator has to redo portion that failed
  • If no growth observed, test is negative and operator has passed the test

 

Supervisor acknowledgement of no growth after 2 weeks:

 

Signature: _______________________________________    Date: ____________________

 

 

 

Hazardous Clean Room Certification Process

 

Hazardous Compounding Validation Testing Procedures with Equashield®

 

Video Training for First-Time Participants:

Before completing the media fill test for the first time, participants should watch the ASHP Compounding Sterile Products video (approximately 60 minutes) and complete the Cleanroom Certification Assessment (quiz).

 

Participants should also watch Equashield Training Video at http://www.equashield.com/how-to-use.

• The following short videos will be the most helpful*
  • Withdrawing From a Vial
  • Preparing an IV Bag with Any Tubing
  • Reconstitution with a Diluent Vial
  • Syringe to Syringe Transfer

 

* It should be noted that while these Equashield videos demonstrate proper use of the Equashield closed-system they do not show the correct technique to use while working in a vertical flow BSC. Participants should be careful to always hold syringes, vials, and bags at angle so as not to obstruct airflow from above. It is also important to swab any adapter ports with alcohol that may be contaminated.

 

Each Media Fill Test requires the following supplies:

CHEMOTEQ^TM Validation Kit Supplies:

• (1) Vial of red of 25 mL Chemoteq media
• (1) Vial of red of 50 mL Chemoteq media
• (1) Package of bag/bottle labels (for 1 vial, 1 syringe, 1 bag)

 

Equashield® Supplies:

• (2) Spike Adapter 1T
• (4) Vial adapters size 20
• (3) 35 mL syringes
• (1) 20 mL syringe
• (3) 10 mL syringes
• (3) 3 mL syringes
• (1) Luer Lock Adapter LL-1DC (syringe to syringe connector)

Additional supplies required:

• (1) 50mL bag normal saline
• (1) 250 mL empty bag
• (1) 10mL or larger empty sterile vial
• (1) Administration tubing set
• (1) Vial 50 ml sterile water for injection (SWFI)
• (1) Vials 50 ml NS for injection

 

Garbing Procedures:

Date:________________________

Completed	Procedure	Comments
	Remove jewelry / outerwear
	Put on shoe covers / cleanroom shoes
	Puts on appropriate mask (N95)
	Puts on bouffant
	Wash hands and forearms for at least 30 seconds
	Dry hands with lint free wipes
	Put on gown and boots
	Put on second pair of boot covers
	Put on goggles
	Disinfect hands with sterile alcohol
	Put on nonsterile chemotherapy gloves
	Disinfect gloves with sterile alcohol
[Enter hazardous clean room]
	Put on chemotherapy gown
	Put on sterile gloves
	Disinfect gloves with sterile alcohol

 

Validation procedure:

Completed	Procedure	Comments
	Clean hood properly with sterile alcohol (top to bottom, back to front)
	Open chemo mat in hood
	Spray each component with alcohol prior to placing it in the hood
	Spray gloves before entering the hood to begin your preparation
	If hands leave the hood for any reason, the must be resprayed with alcohol prior to re-entering
	Wipe down all ports with alcohol swabs ; wipe down any vial tops throughout process with alcohol swabs
	Spike empty 250 mL bag with spike adaptor 1
	Attach administration set to the 50 mL normal saline bag, prime the tubing, and clamp to prevent leakage (Spike adaptor 1 and tubing)
	Put vial adaptor size 20 on NS vial and withdraw 50 mL then transfer to the 250 mL empty bag using equashield syringe (Use 35 mL syringe and transfer 25 mL at a time)
	Put a vial adaptor size 20 on a VM-50 vial and transfer to the 250 mL empty bag using a new equashield syringe (Use 35 mL syringe and transfer 25 mL at a time)
	Put vial adaptor size 20 on a 50 mL sterile water vial and another vial adaptor size 20 on a VM-25 vial. Withdraw 25 mL of sterile water (using new 35 mL equashield syringe) and inject into VM-25 vial.
	Using 10 mL equashield syringes, draw up 7 mL into each of the 3 syringes from VM-25
	Inject 2 of the syringes into 250 mL bag
	Using 3 mL equashield syringes, draw up 1 mL into each of the 3 syringes from VM-25
	Inject all 3 of the syringes into the 50 mL normal saline bag
	Draw up 1 mL of sterile water into a 20 mL syringe
	Using a LL-1 DC luer lock adaptor, connect the sterile water syringe to the 7 mL syringe filled with media
	Transfer the media into the sterile water syringe then disconnect the syringes
	Cap syringe with sterile vial cap
	Label vial, bag, and syringe with date and operator’s initials. (Keep adapters on the vials.)
	Collect bag, vials and syringe in Ziploc bag [[Supervisor : monitor for growth for 2 weeks]]

Cleaning and De-garbing:

Completed	Procedure	Comments
	Dispose of all syringes and vials in blue chemo bin
	Dispose of all plastic, wrappers, and chemo mat in trash can
	Clean hood with alcohol (top to bottom, back to front)
	Remove sterile gloves, chemo gloves, and chemo gown in chemo room
	De-garb in anteroom in reverse order

Once out of the cleanroom – (For Pharmacist)

• Label the final bag
• Immediately inspect bag for particulates, coring, fibers
  • Nothing should be present in the bag and if it is then it should be recorded as to not be mistaken with microbial growth later on
• Incubate at room temperature for 14 days
• Examine daily for turbidity
  • If turbidity is observed, growth from microorganisms is indicated and the test is positive
  • If the bag is clear, the test is negative and the operator has passed the test

 

 

Supervisor acknowledgement of no growth after 2 weeks:

 

Signature: _______________________________________    Date: ____________________