In contamination control, every step matters—from cleanroom design and supplies to disinfection, monitoring, and disciplined aseptic technique. When formulation, container-closure, and packaging allow, terminal sterilization can provide an additional, independent layer of sterility assurance. MediZap delivers that layer through contract E-Beam | X-Ray irradiation technology, purpose-built for sterile compounders and small-pharma organizations.
MediZap is the only contract terminal sterilizer by E-Beam | X-Ray irradiation built for compounders and pharma. We support hospital and health system pharmacies, 503A compounding pharmacies, 503B outsourcing facilities, and small-pharma manufacturers—helping teams strengthen contamination control with terminal sterilization programs designed for speed, scalability, and quality-system rigor.
Sterile compounding starts in a compliant cleanroom, but sterility assurance depends on the entire process. When you need an added layer of protection beyond high-risk aseptic manipulations, MediZap provides a validation-minded program with dedicated capacity, fast turnaround, and documentation your quality team can defend.
AT-A-GLANCE DIFFERENTIATORS
- Fast turnaround aligned with pharmacy operations
- Dedicated capacity—no advance reservations required
- High sterility assurance targets, including 10^-6 SAL (when applicable)
- Advanced irradiation options: E-Beam and X-Ray
- A compounding-focused center of excellence supported by multi-layer quality oversight
WHO WE SERVE
- Hospital and health system pharmacies (including affiliated 503A/503B operations) managing risk, shortages, and urgent care needs
- 503A compounding pharmacies seeking scalable pathways to high sterility assurance
- 503B outsourcing facilities building inspection-ready documentation and repeatable operations
- Small-pharma and specialty manufacturers seeking a reliable contract sterilization partner
WHY TERMINAL STERILIZATION
- Reduce reliance on high-risk aseptic manipulations where appropriate
- Support consistent sterility outcomes across scale-up to routine runs
- Improve operational confidence for high-consequence sterile products
- Complement USP 797 expectations and cGMP quality systems
- Create an additional control point that can simplify investigations and trend review
HOW MEDIZAP SUPPORTS CLEANROOM CONTAMINATION CONTROL
Cleanroom supplies and disposables help maintain a controlled environment during preparation. MediZap complements those controls by strengthening sterility assurance after fill and seal, adding an independent sterilization step where terminal sterilization is appropriate.
STERILIZATION TECHNOLOGY (E-BEAM | X-RAY)
MediZap offers irradiation-based terminal sterilization programs selected to match your product and packaging needs:
- E-Beam irradiation: rapid processing, high throughput, responsive scheduling
- X-Ray irradiation: deeper penetration and geometry flexibility for specific configurations
- Dose mapping and robust validation pathways to support defined sterility assurance targets
- A standards-aligned approach informed by ISO 11137 and ISO 11737 principles
VALUE PROPOSITION
Why MediZap is purpose-built for compounders and pharma:
- Extension: scale with your business using scalable lot sizes
- Duration: same-day to 48-hour turnaround, processing on your schedule, 5 days a week
- Completion: concept-to-commercialization experience to support program maturity
- Integration: access to contract research laboratory partners as needed
- Pre-validation: packaging solutions and pathways made for compounded sterile preparations
- Education: sterility assurance excellence education built for compounders
- Advocacy: championing higher sterility assurance through alignment with USP, ISO, and regulatory expectations
FOUR PILLARS THAT KEEP YOUR PROGRAM MOVING
1. Advanced Sterilization
- Terminal sterilization programs with robust validation and dose mapping
- Routine processing pathways designed for repeatability and scale
- A quality mindset built around sterility assurance, traceability, and audit readiness
2. Packaging Solutions
- Packaging and handling support aligned with sterile preparations
- Guidance to help evaluate packaging compatibility with irradiation
- Practical recommendations that fit cleanroom workflow and downstream distribution needs
3. Compliance Support
- Support aligned with USP 797 expectations and cGMP thinking
- Document control and SOP support to help strengthen internal quality systems
- A structured approach that helps teams build defensible records and trends over time
4. Exclusive Partnerships
- Integrated partners focused on keeping projects moving from early development through routine operations
- Access to contract laboratory resources for microbiology and analytical chemistry testing requirements
- Collaboration that respects timelines, supply continuity, and patient care priorities
WHAT A MEDIZAP PROGRAM CAN LOOK LIKE
While each program is tailored to product, packaging, and quality-system requirements, MediZap typically supports a clear pathway from feasibility through routine processing:
- Fit assessment: confirm that terminal sterilization is appropriate for the formulation and container-closure system
- Pre-validation planning: define packaging configuration, handling, and documentation expectations
- Dose mapping and validation: establish parameters, acceptance criteria, and monitoring strategy
- Routine processing: execute repeatable runs with batch records, traceability, and QA-ready data packages
- Scale and sustain: support changes in volume, packaging, or product mix while maintaining control
QUALITY SYSTEM ALIGNMENT
MediZap brings subject-matter expertise, advanced technology systems, and a quality-first culture. We operate in accordance with FDA expectations, USP standards, State Boards of Pharmacy, and DEA-regulated environments, supported by multi-layer quality oversight. Our goal is to help you deliver sterile products with high practical sterility assurance while maintaining clear, reviewable records.
WHAT TO EXPECT IN YOUR DOCUMENT PACKAGE
- Clear batch-level records and traceability
- Defined process parameters and monitoring expectations
- Validation summaries and supporting data (as applicable)
- A structure that promotes audit and inspection readiness
WHAT QUALITY TEAMS CARE ABOUT (AND HOW WE HELP)
Quality teams want clarity, repeatability, and defensibility. MediZap emphasizes:
- Traceability: clear linkage between lot, processing conditions, and documentation
- Repeatability: a program that behaves the same way in routine runs as it did in qualification
- Defensibility: records structured for internal review and external scrutiny
- Standards-based thinking: alignment with the intent of ISO sterilization standards and sound microbiological contamination control principles
If you are strengthening sterility assurance, expanding capacity, or seeking a partner that understands both compounding and pharma-quality expectations, MediZap delivers advanced terminal sterilization with speed, rigor, and a commitment to excellence in sterility assurance.