"Insourcing" Sterile I.V. Compounding Services

Cleanroom Tool

Designing a clean room is a complex process. The design below was shared by a health-system with a central fill model registered as a manufacturer. In addition to being able to see how one facility has designed their cleanroom, click on the highlighted icons within the design to see details for each part of the clean room that facilities should consider when designing a clean room.

  This is an interactive illustration. Hover your mouse over the star icon for more information.

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CGMPs require 100% visual inspection of all compounded medications. USP Chapter <797> requires particulate matter inspection and the use of a light table will aid in this quality metric.
When labeling batches, an area clearance needs to be performed to prevent label mix-ups and labeling errors. Label accountability is a key quality metric. Only one batch should be labeled at a time and once completed, the area should be inspected and cleared of all materials/labels,etc. from the prior batch.
QC function in an outsourcing facility, especially a 503B entity is critical to ensure the quality of CSPs. This function needs to be independent of the production and permitted to accept or reject CSPs based on pre-determined specifications and NOT subjected to financial pressures. Quality assurance programs are also outlined in USP Chapter <797>.
Proper supervision is critical in outsourcing/503B facilities. This person will be responsible for the overall quality of the operation and compliance with all SOPs/PnPs.
All inbound components need to be quarantined until they have been determined to be acceptable for use. All compounded drugs waiting for sterility test results need to be quarantined so that they are not released until the results of the testing is received. If a 503 B facility, FDA may require samples of CSPs from each batch to be retained for the duration of the BUD.
A pass-thru will facilitate the transfer of components and supplies that will be used when compounding. All finished compounded drugs should exit the buffer area through a different pass-thru to facilitate an one-way workflow. This will minimize mixups and errors.
Cleanroom scrubs should be worn only in the ISO classified areas. If staff leave for lunch, breaks, etc., they should change into their "street clothes".
Be aware of DEA regulations when compounding narcotics. DEA requires a separate manufacturer's registration when preparing non-patient specific narcotics. You will need to take these into building, mixing, and quarantine workflow considerations. Cameras or other security devices may be needed in certain areas depending on DEA regulations.
Garbing requirements differ between USP Chapter <797> and CGMPs. The FDA expects that sterile garb will be worn in 503 B registered facilities, which is a different expectation from USP Chapter <797>.
A janitor's closet will allow for the storage of dedicated equipment and preparation of sterile cleaning and disinfecting agents.