Practical, regulation-aligned clinic setup for gynecologists and hospitals.
Establishing an ART Level 1 clinic requires meticulous planning across multiple dimensions. Our deep-dive approach ensures no aspect is overlooked in your journey to certification.
Strategic planning of your physical space to optimize workflow while meeting regulatory requirements.
Precise specification of mandatory and recommended equipment for compliant operations.
Strategic staffing planning and competency development for sustainable operations.
| Equipment Type | Specifications | Status | Purpose |
|---|---|---|---|
| Centrifuge | Swing-out rotor, temperature control, 300-400g force | Mandatory | Sperm washing and processing |
| Microscope | Phase-contrast, 10x-40x objectives, heated stage | Mandatory | Semen analysis and motility assessment |
| Biosafety Cabinet | Class II, HEPA filtered, 4ft working area | Mandatory | Aseptic sample processing |
| Refrigerator | 2-8°C, digital temperature display, alarm | Mandatory | Reagent and media storage |
| Incubator | CO2, 37°C, humidity control | Recommended | Future IVF expansion |
| UPS System | 1KVA minimum, 30-minute backup | Recommended | Power backup for critical equipment |
A robust documentation system is the foundation of audit readiness and quality assurance.
Our proven 5-step implementation process ensures systematic progress from concept to certification.
Assessment & Planning
Space Optimization
Procurement Planning
Staff Development
Certification Readiness
Realistic financial planning and timeline management are crucial for successful clinic setup.
Core lab equipment and consumables
Renovation, electrical, plumbing
Implementation support & staff training
From assessment to certification readiness
Note: Budget ranges vary based on clinic size, existing infrastructure, equipment choices, and location-specific factors.
Which equipment is mandatory for ART Level 1?
The absolute mandatory equipment includes: sperm processing centrifuge, phase-contrast microscope, biosafety cabinet/laminar flow hood, temperature-controlled refrigerator, and documented SOPs. Additional equipment enhances capabilities but these form the core requirement for basic IUI and sperm processing operations.
Can ART Level 1 expand to IVF later?
Yes, and we strongly recommend planning for future IVF expansion during the initial setup. This includes allocating additional space, ensuring adequate electrical capacity, and selecting equipment that can scale (like incubators with IVF capabilities). Strategic planning during ART Level 1 setup can reduce future upgrade costs by up to 65%.
What is the minimum space requirement?
The minimum recommended dedicated space is 150-200 square feet. However, the optimal size depends on your expected patient volume, workflow design, and whether you're planning for future expansion. We conduct detailed space analysis during the assessment phase to determine the ideal configuration for your specific needs.
Every clinic has unique requirements. Schedule a comprehensive site assessment to receive a customized setup plan and accurate budget estimation.
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