MediZap

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.