Quality Control USP 797
Sterile Non-Hazardous Compounding <797>
Purpose/ Applicability: To provide a guideline which clearly delineates how quality control is being handled for CSPs.
Scope: This applies to all CSPs being tested for sterility.
CSP: Compounded sterile product
BUD: Beyond use date
- Based on USP <71>, 10% of each batch for each repackaged drug will be sent to the VDL for sterility testing
- (Starting 3/12/21, only one unit per batch needs to be sent unless determined otherwise)
- Sterility testing will be done in accordance with USP <71>
- Results of sterility testing will be sent to firstname.lastname@example.org.
- Sterility testing will be charged to the Pharmacy FOP (301732-255060-255006)
- When testing controlled substances, a pharmacist will arrange to meet with the VDL technician completing the testing. This pharmacist will supervise the use of the controlled substances and then bring back any unused drug for wasting in the medication dispensary.
- Non-controlled medications can be left with the VDL technician for testing after the pharmacist leaves.
- When a batch of medication is prepared in the cleanroom, 10% will be calculated on the repackaging log. That number of units will be pulled out randomly for sterility testing. A unit must have at least 0.2 ml of drug.
- Starting with batches on 3/12/21, only one unit needs to be pulled to be sterility tested unless positive results are returned from any batch. In this case, testing will be returned to 10% or a minimum of four units.
- Once weekly, a pharmacist will arrange a meeting with the VDL technician Molly, to submit the samples.
- Molly can be contacted at email@example.com. For controlled substances, the pharmacist will need to be present while the medication is being aliquoted. For non-controls, they can be left for aliquoting at a later time.
- Prior to taking the samples to be tested, a VDL Sample Submission form needs to be completed. The following is the information to provide:
Veterinarian: Julia Whittington
Billing Comments: Pharmacy
Copy Results: firstname.lastname@example.org and check the ‘other’ box
Check ‘drop off’
Specimen: Swab site vial
Under cultures, check ‘Environmental/C&D’
History or additional information (pg 2): Pharmacy
Complete the total number of samples and list one line for each unit being sampled (pg 2)
- Number each vial/syringe label with the number corresponding to the line number on the sheet.
- Update the microbial testing spreadsheet in the shared drive with the samples being submitted.
- VDL technician will perform the sterility testing as follows:
- Fifty microliters of drug will be directly plated on a Columbia agar containing 5% sheep blood and a Cholate agar plate and incubated under 37ᵒC with 5% CO2 for at least 48 hours to screen the growth of bacteria.
- Fifty microliters of drug will be also inoculated into 10 ml Thioglycollate enrichment broth and inoculated at 37ᵒC incubator for 48 hrs. Growth of bacteria will be determined by checking the turbidity of medium. If the Thioglycollate turns cloudy, 1-5 µl of medium will be plated on Columbia agar containing 5% sheep blood and incubated under 37ᵒC with 5% CO2 for at least 48 hours to confirm the growth of bacteria.
- If any bacterial colonies were noticed on the culture plates, they will be further identified using MALDI-TOF and a quantitative result shown as CFU/ml may be provided by VDL to indicate bacterial numbers presenting in the drug.
- The pharmacist will return any unused controlled substances to the medication dispensary for appropriate wasting.
- When the preliminary results are received, the microbial testing spreadsheet will be updated to reflect the results. When the final results are received, the spreadsheet will be updated with any changes.
- If a sample is positive, the entire lot will need to be recalled and wasted as contaminated.
Once final sterility testing results have been received, the repackaging log should be marked as follows.
- If the results are all negative, place a check mark next to the number sent for sterility testing
- If any positive results are obtained, circle the number sent for sterility testing and write the date the lot was wasted.
If two positive results are received in a row, processes and procedures should be reassessed to ensure that a sterile environment is being maintained during repackaging.