PharmEng Taiwan
Pharmaceutical Engineering Specialist
- GMP GLP GDP Facility Design-Build
- Clean Room Engineering
- HVAC System Engineering
- Purified Water System Engineering
- M&E System Engineering
- Process Gas System Engineering
- BMS EMS System Engineering
PharmEng Global
- GMP GLP GDP Quality System
- Halal Quality System
- Biologics & Chemical Processes & Dosage Forms
- Global Regulatory Affairs
Services
GMP GLP GDP Facility Design-Build
Professional GMP-, GLP-, GDP-, ISO 13485-, ISO 14644-compliant manufacturing, laboratory, and warehouse facility design and engineering services, in accordance with different lifecycle phase of the dosage form, biosafety category, clinical phase, and marketing lifecycle of your product.
Clean Room Engineering
Project management, concept design, detailed design, drafting, URS preparation, commissioning, TAB, qualification, and validation.
HVAC System
PIC/S GMP Grade A, B, C, D cleanliness zones, ISO 14644-compliant cleanrooms, biosafety-compliant cleanrooms, high potency facilities, cytotoxic facilities, product warehouses, stability rooms, and other HVAC system engineering, qualification, and validation.
High Purity Water
Pre-treatment, RO/DI water generation system, purified water generation system, WFI generation system, pure steam generation system, ASME BPE grade loop system engineering, qualification, and validation.
M&E System
Interior utility hook-up, low voltage, extra low voltage, cleanroom lighting, outlets, access control, ethernet, telephone, CCTV, and other M&E system engineering, qualification, and validation.
Process Gas
Medical gas, process compressed dried air (CDA), nitrogen, liquid nitrogen, oxygen, carbon dioxide, and other process gas generation and distribution system engineering, qualification, and validation.
BMS EMS Controls
Building Management System (BMS) engineering, Environmental Monitoring System (EMS) engineering, System Interation Testing (SIT), User Acceptance Testing (UAT), computerized system validation (CSV).
Projects
Together with PharmEng Global offices, we provide full facility lifecycle, full product lifecycle validation, quality system, CMC writing, and execution.
Validation Master Plan | Facility Qualification | Utilities Qualification | Sterilization Validation | Thermal Validation | Cleaning Validation | Analytical Method Validation | Process Validation
VMP | DQ | RA | IQ | OQ | PQ | CV | PV
PharmEng Global
PharmEng Technology is an international, full-service consultancy that serves the pharmaceutical, biotechnologyand medical device industries globally. Consulting services include:
• Validation • Engineering • Product Development • Quality Systems • Professional Training •
• Medical Devices • Regulatory Affairs • Project Management •
PharmEng’s primary consulting focus is to work in close collaboration with clients to provide innovative and cost-effective solutions to help maintain their competitive advantage. Along with a focus on service quality, PharmEng has emerged as a worldwide leader in pharmaceutical consulting. The Company’s success is demonstrated by the numerous long-term relationships PharmEng has developed in the pharmaceutical, biotechnology, nutraceutical, healthcare, API (active pharmaceutical ingredients), and medical device sectors. Our winning formula of working in collaboration with our clients is demonstrated by the long-term relationships we have developed in the industry.
聯絡我們
台灣 | TAIWAN
11F-5, No. 91, Hua-Yin Street, Taipei 103
E: info@pharmeng.tw
T: (02) 2555 0125
Contact Us
總公司 | Head Office
23 Lesmill Road, Suite 410
Toronto, Ontario
Canada, M3B 3P6
E: info@pharmeng.com
T: +1 416 385 3922