Understanding Sterile Compounding
- What is sterile compounding: preparation of medications that must be free from microorganisms
- Used for: injections, IV medications, eye drops, other sterile products
- Critical importance: contaminated sterile products can cause serious infections or death
- Examples: hormone injections (testosterone, semaglutide), peptides, IV nutrients, pain management injections
- Difference from non-sterile compounding
- Why specialized facilities are required
- Historical context: 2012 NECC outbreak that killed 64 people from contaminated steroid injections
USP 797 Standards
- USP (United States Pharmacopeia) sets pharmaceutical standards
- USP 797 specifically addresses sterile compounding
- Key requirements: cleanroom facilities, environmental monitoring, personnel training, quality control procedures, beyond-use dating, documentation
- Risk levels: Low risk (simple sterile-to-sterile transfer), Medium risk (multiple ingredients or complex procedures), High risk (non-sterile ingredients made sterile)
- Compliance is mandatory for pharmacies doing sterile compounding
- State boards of pharmacy enforce USP 797
- Regular updates to standards (most recent 2019, new version 2023)
Cleanroom Design and Classification
- ISO classifications: ISO 5 (Class 100), ISO 7 (Class 10,000), ISO 8 (Class 100,000)
- Primary engineering control (PEC): Laminar airflow workbench or biological safety cabinet, ISO 5 environment, HEPA filtration, unidirectional airflow
- Buffer room (ISO 7): Surrounds the PEC, Positive pressure, HEPA-filtered air, Where compounding occurs
- Ante-room (ISO 8): Entry area, Garbing and hand hygiene, Transition zone
- Air pressure cascade: Cleanest area (ISO 5) has highest pressure, Prevents contaminated air from entering, Pressure differential maintained
- HEPA filtration: High-Efficiency Particulate Air filters, Remove 99.97% of particles 0.3 microns or larger, Continuous air filtration
- Temperature and humidity control: Specific ranges maintained, Affects product stability, Monitored continuously
- Surfaces and materials: Non-porous, easy to clean, No particle shedding, Stainless steel common
Environmental Monitoring
- Viable particle testing: Air sampling for microorganisms, Surface sampling, Personnel monitoring, Frequency based on risk level
- Non-viable particle counting: Measures airborne particles, Verifies ISO classification, Performed regularly
- Pressure differential monitoring: Ensures proper airflow, Continuous monitoring, Alarms if out of range
- Temperature and humidity: Continuous monitoring, Documented records, Out-of-range investigations
- Action levels and alert levels: Predetermined limits, Trigger investigations, May require facility remediation
- Documentation: All monitoring results recorded, Trends analyzed, Deviations investigated
Personnel Training and Garbing
- Initial training requirements: Aseptic technique, Garbing procedures, Cleanroom behavior, Hand hygiene, Product preparation
- Competency assessment: Initial and annual testing, Media fill testing (process simulation), Gloved fingertip sampling, Observation of technique
- Garbing procedure: Specific order must be followed, Includes: shoe covers, hair cover, face mask, gown, gloves, Hand hygiene critical
- Cleanroom behavior: No talking, coughing, sneezing near critical areas, Slow, deliberate movements, No unnecessary items in cleanroom, Proper body positioning
- Health and hygiene: No jewelry, artificial nails, cosmetics, Report illness, Handwashing technique critical
- Ongoing training: Regular refreshers, Updates on procedures, New product training
Quality Control Procedures
- Ingredient verification: Certificates of analysis, Visual inspection, Proper storage
- Compounding verification: Double-check calculations, Verify measurements, Document all steps
- End-product testing: Sterility testing (for high-risk), Endotoxin testing, Potency testing (when applicable), Visual inspection
- Beyond-use dating: Based on risk level and testing, Conservative dating without testing, Extended dating with stability data
- Environmental monitoring results review
- Equipment calibration and maintenance: Balances, Measuring devices, Autoclave (if used), HEPA filters
- Standard operating procedures (SOPs): Written procedures for all activities, Regularly reviewed and updated, All personnel trained on SOPs
- Documentation: Compounding records, Batch records, Quality control results, Deviations and investigations
Advanced Scripts’ Sterile Facility
- State-of-the-art cleanroom facility
- Meets all USP 797 requirements
- ISO 5 primary engineering controls
- ISO 7 buffer room
- ISO 8 ante-room
- Continuous environmental monitoring
- Highly trained compounding staff
- Regular competency assessments
- Comprehensive quality control program
- LegitScript certified
- State board inspected and approved
- Pharmaceutical-grade ingredients only
- Rigorous documentation
- Next-day delivery throughout Florida
- Expert pharmacist consultations
- Specializing in: hormone injections, peptides, weight loss medications, pain management compounds
Frequently asked questions
07. What is media fill testing?
Yes, when performed by a qualified, accredited compounding pharmacy, pharmaceutical compounding is very safe. Reputable compounding pharmacies follow United States Pharmacopeia (USP) guidelines and implement rigorous quality control measures. Choosing a LegitScript-certified pharmacy like Advanced Scripts ensures your medications are prepared to the highest safety and quality standards.
About the Author: Prepared by Advanced Scripts Pharmacy pharmaceutical experts.
Fast and Reliable Shipping
At Advanced Scripts Pharmacy, we understand the importance of timely access to your child's medications. That's why we offer fast, reliable shipping nationwide. No matter where you are in the United States, our customized compounded therapies can be delivered right to your doorstep with next-day shipping options available for most prescriptions. Your child's health shouldn't have to wait.