KHLAB PIVAS Laboratory Engineering & Turnkey Design Services
| Brand | KHLAB |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Authorized Distributor |
| Product Origin | Domestic (China) |
| Model | PIVAS (Pharmacy Intravenous Admixture Services) Facility |
| Quotation | Upon Request |
| Design Experience | 10+ Years |
Overview
KHLAB’s PIVAS (Pharmacy Intravenous Admixture Services) Laboratory Engineering & Turnkey Design Services deliver comprehensive, regulatory-compliant facility solutions for hospital pharmacy departments and central intravenous admixture units. Engineered to meet the stringent requirements of China’s Technical Specifications for Construction of Intravenous Admixture Centers (WS/T 395–2013), as well as international Good Manufacturing Practice (GMP) principles and ISO 14644-1 Class 5 (ISO Class 5) cleanroom standards, this service integrates architectural planning, HVAC system design, cleanroom construction, and critical process equipment integration into a single coordinated delivery framework. The core objective is to ensure sterility assurance, personnel safety, and operational traceability across all phases—from hazardous drug compounding to final product release—within a validated, auditable infrastructure.
Key Features
- Regulatory-Aligned Facility Architecture: Layouts adhere to strict unidirectional workflow zoning (e.g., clean preparation area → anteroom → buffer room → laminar flow hood zone), minimizing cross-contamination risk and supporting compliance with national PIVAS accreditation criteria.
- Integrated Cleanroom Engineering: Full-scope cleanroom design—including HEPA-filtered ceiling modules, pressure cascade control systems, and continuous particle monitoring interfaces—ensuring sustained ISO Class 5 (≤3,520 particles/m³ ≥0.5 µm) performance in primary compounding zones.
- Critical Equipment Integration: Seamless specification, installation, and commissioning support for Class II B2 biological safety cabinets (BSCs), horizontal laminar airflow workbenches (HEPA-filtered, 0.3 µm @ ≥99.99%), stainless-steel pharmaceutical-grade lab benches, emergency eyewash and shower stations (ANSI Z358.1 compliant), and redundant power/data infrastructure.
- Validation-Ready Documentation Package: Includes IQ/OQ protocols, as-built drawings, HVAC performance reports, airflow visualization records, and material compatibility assessments—structured to facilitate internal QA review and third-party regulatory audits.
- Multi-Disciplinary Coordination: In-house coordination between architectural, mechanical, electrical, and pharmaceutical engineering disciplines ensures alignment of structural load capacity, utility routing (e.g., medical gases, purified water), and environmental monitoring system (EMS) integration points.
Sample Compatibility & Compliance
This service is designed exclusively for sterile pharmaceutical preparation environments handling cytotoxic, antibiotic, and parenteral nutrition formulations. All spatial configurations, material selections (e.g., epoxy-coated steel, seamless PVC flooring), and ventilation strategies comply with WS/T 395–2013, GB 50346–2011 (Bio-safety Laboratory Construction Standards), and reference GMP Annexes on Sterile Manufacture. While not a device subject to FDA 510(k) or CE marking, the engineered environment supports adherence to ISO 13485 quality management systems and prepares facilities for GLP/GMP readiness assessments. Documentation packages are structured to align with hospital QA/QC department requirements and provincial health commission inspection checklists.
Software & Data Management
KHLAB provides standardized digital deliverables including AutoCAD-based as-built drawings, Revit-compatible BIM models (Level 2 LOD), and Excel-based validation traceability matrices. Optional add-ons include integration-ready interfaces for facility EMS platforms (e.g., Vaisala viewLinc, Siemens Desigo CC), enabling real-time temperature, humidity, differential pressure, and particle count data logging with configurable alarm thresholds. All electronic documentation conforms to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) to support long-term record retention and audit defense.
Applications
- Hospital-based PIVAS facility development and expansion projects
- Renovation and revalidation of legacy IV admixture units
- Regional medical center central pharmacy consolidation initiatives
- Academic medical centers requiring dual-use (research + clinical compounding) cleanroom infrastructure
- Public health institutions implementing standardized oncology drug preparation workflows
FAQ
Does KHLAB provide turnkey construction or only design services?
KHLAB delivers end-to-end engineering services—from conceptual layout and HVAC design through equipment specification and commissioning support—but does not act as general contractor. We partner with licensed civil and MEP contractors vetted for healthcare facility experience.
Can the design accommodate hazardous drug handling per USP <797> or <800>?
While primarily aligned with Chinese PIVAS standards, our layouts and BSC specifications can be adapted to incorporate USP <797>/<800> requirements—including segregated negative-pressure C-PECs and vapor barrier containment—upon client request and jurisdictional validation scope.
What documentation is delivered upon project completion?
Final deliverables include full as-built drawings, cleanroom certification reports (airborne particle counts, airflow velocity/visualization, pressure differentials), equipment installation & operation qualification summaries, and a master validation index referencing all IQ/OQ/PPQ documents.
Is remote commissioning support available for international clients?
Yes—KHLAB offers virtual commissioning assistance, including remote witness testing, digital handover sessions, and English-language SOP templates for facility startup and routine monitoring procedures.
