A Visual Guide to PharMEDium’s
Sterile-to-Sterile Compounding Process

Only FDA-approved* commercially available sterile drugs and medical devices cleared by the FDA are used to produce our ready to use Compounded Sterile Preparations (CSPs).

Step 1

Validation of Incoming Materials

Each item received is reviewed against a PharMEDium specification and the incoming Certificate of Analysis (COA) or Certificate of Conformity (COC) at the time of receipt. The barcode is scanned at every step in our process.


Step 2

Staging

Only FDA-approved sterile finished drug components* are used. We track components all the way to the point of care, using 200% verification of all steps in our process.


Step 3

Prep

Pass-in is key. Sterile barriers and aseptic techniques safeguard against contamination. Each batch’s materials are prepped and decontaminated with approved sporicidal agents before going into our ISO certified clean rooms.


Step 4

Aseptic Environment

Daily sporicidal use helps to ensure contamination control of our ISO 7 clean room and our ISO 5 compounding and lling environments. Only trained personnel wearing single-use sterile gowning are allowed access in our clean rooms.


Step 5

Compounding

In a monitored environment, we conduct environmental and personnel monitoring (EM/PM) testing on 100% of our batches. EM/PM results are directly tied to batch release.


Step 6

Filling

PharMEDium is at the forefront of automation. With semi-automated transfer pumps and fully automated ISO 5 hoods and filling equipment we help to guard against contamination by limiting the amount of human interaction with our CSPs.


Step 7

Lab Testing

Every batch undergoes rigorous quality control testing following compendial USP-NF (United States Pharmacopeia and the National Formulary) or alternative methods for the examination of drug products. We utilize state-of-the-art technology such as ScanRDI®, fully automated robotic systems like Endosafe® NexusTM, as well as a multitude of standard and high performance chromatography and spectroscopy equipment. PharMEDium’s in-house cGMP laboratory facilities enable our scientists to rapidly obtain results, reduce variability, streamline analytical processes, and consistently deliver high quality test result to ensure a safe and efficacious drug product.


Step 8

Label & Packaging

Our proprietary labels help to ensure against medication errors through increased readability, prominent expiry dates, and thorough barcoding. TALLman lettering and color coding are added for maximum differentiation. We conduct 100% visual inspection on every unit before the label is applied. Our labels are 100% compliant with the Drug Quality and Security Act (DQSA) requirements.


Step 9

Batch Release

Quality Assurance reviews all documentation associated with compounding and batches. Quality Assurance also reviews all test results for EM/PM to ensure expectations are met and that the tests conform to expectation prior to batch release. A Certificate of Analysis (COA) is created for each batch. Retention samples are pulled for 100% of batches and stored according to label specifications.


Step 10

Shipping

We ensure product accuracy by using barcodes to track your product all the way through the process until it is placed in one of our shipping containers. PharMEDium only uses FedEx and UPS to track your order through point of receipt.


ADVANCING THE SCIENCE BEHIND WHAT WE DO.

PharMEDium performs real-time stability verification through independent FDA-registered laboratories who utilize current Good Manufacturing Practices (cGMPs) when testing our final formulations. We maintain a comprehensive set of technical reports and quality compounding reports available 24/7 available within our Customer Resource Center.

Our testing includes:

  • Storage conditions including temperature cycling
  • Homogeneity
  • Particulate matter
  • Active ingredient drug profiles
  • Shifts in pH
  • Specific container and drug manufacturer
  • Packaging and shipping studies
  • Light sensitivity
  • Sterility integrity of each container/closure combination
  • Bactericidal and fungicidal sterility validation testing

 

*List of available admixtures is subject to change. Please visit PharMEDium’s Customer Resource Center for a current list of available services and new product announcements.

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