Ecer asks for your consent to use your personal data to:
Personalised advertising and content, advertising and content measurement, audience research and services development
Store and/or access information on a device
Your personal data will be processed and information from your device (cookies, unique identifiers, and other device data) may be stored by, accessed by and shared with 135 TCF vendor(s) and 65 ad partner(s), or used specifically by this site or app.
Some vendors may process your personal data on the basis of legitimate interest, which you can object to by do not consent. Contact our platform customer service, you can also withdraw your consent.
Your message must
be between 20-3,000 characters!
Submit Requirement
Thank You!
Your requirement has been sent. we will contact you quickly!
{"title":"Modular , Certified ISO Cleanroom for Biomedical Projects GCC Southeast Asia","imgUrl":"https:\/\/img.chinax.com\/nimg\/6e\/43\/bb9283ee1a44064e8be7d74b1521-200x200-1\/modular_2c_certified_iso_cleanroom_for_biomedical_projects_gcc_southeast_asia.jpg","attrs":{"Brand Name":"GCC","Certification":"ISO\/GMP\/CE","Place of Origin":"Guangdong,China","Minimum Order Quantity":"1"}}
{"title":"Aluminum Profile GMP Cleanroom with 0.45 m\/S ISO Class 8 for Pharmaceutical Use","imgUrl":"https:\/\/img.chinax.com\/nimg\/e3\/d0\/891c990311c6f6f77fcb5d94ba48-200x200-1\/aluminum_profile_gmp_cleanroom_with_0_45_m_2fs_iso_class_8_for_pharmaceutical_use.jpg","attrs":{"Brand Name":"GCC","Certification":"ISO\/GMP\/CE","Place of Origin":"Guangdong,China","Minimum Order Quantity":"1"}}
{"title":"Large 100 m2 Prefab Cleanroom with 18 FFU for Modular Cleanroom Southeast Asia","imgUrl":"https:\/\/img.chinax.com\/nimg\/46\/05\/c3e3a2454a010baa97ef1cb2da0a-200x200-1\/large_100_m2_prefab_cleanroom_with_18_ffu_for_modular_cleanroom_southeast_asia.jpg","attrs":{"Brand Name":"GCC","Certification":"ISO\/GMP\/CE","Place of Origin":"Guangdong,China","Minimum Order Quantity":"1"}}
{"title":"Modular Cleanroom 50 m2 with 9 FFU for Pharmacy Air Cleanliness Control","imgUrl":"https:\/\/img.chinax.com\/nimg\/67\/29\/ad098f5b93c003f2f8c40913ebd8-200x200-1\/modular_cleanroom_50_m2_with_9_ffu_for_pharmacy_air_cleanliness_control_southeast_asia.jpg","attrs":{"Brand Name":"GCC","Certification":"ISO\/GMP\/CE","Place of Origin":"Guangdong,China","Minimum Order Quantity":"1"}}
{"title":"Durable , Modular ISO4 Class 10 Cleanroom for Aseptic Applications GCC Southeast","imgUrl":"https:\/\/img.chinax.com\/nimg\/a3\/3d\/809556c69b36c7ace43f7cc2c8c7-200x200-1\/durable_2c_modular_iso4_class_10_cleanroom_for_aseptic_applications_gcc_southeast_asia.jpg","attrs":{"Brand Name":"GCC","Certification":"ISO\/GMP\/CE","Place of Origin":"Guangdong,China","Minimum Order Quantity":"1"}}
{"title":"Dust Free , High Precision Class 100000 Cleanroom for Laboratory Use GCC","imgUrl":"https:\/\/img.chinax.com\/nimg\/56\/e8\/f99074ff88bf33a61983f78a1db1-200x200-1\/dust_free_2c_high_precision_class_100000_cleanroom_for_laboratory_use_gcc_southeast_asia.jpg","attrs":{"Brand Name":"GCC","Certification":"ISO\/GMP\/CE","Place of Origin":"Guangdong,China","Minimum Order Quantity":"1"}}
{"title":"ISO Mobile PCR Cabin Laboratory 30 KW Prefab Cleanroom Container with Cleanroom","imgUrl":"https:\/\/img.chinax.com\/nimg\/29\/0e\/88748eeec213759cb647a78520d9-200x200-1\/iso_mobile_pcr_cabin_laboratory_30_kw_prefab_cleanroom_container_with_cleanroom_wall_system.jpg","attrs":{"Brand Name":"GCC","Certification":"ISO\/GMP\/CE","Place of Origin":"Guangdong,China","Minimum Order Quantity":"1"}}
We specialize in providing integrated cleanroom design, construction, and validation services that meet international standards (ISO/GMP) for the pharmaceutical, medical device, biotechnology, and research institute sectors. From gene therapy to sterile manufacturing, from lab R&D to large-scale production, we leverage cutting-edge technology, rigorous quality control, and full life-cycle services to build safe, reliable, and compliant clean environments for you. We ensure product purity, process integrity, and operational efficiency.
Features
Compliance First
Strict adherence to China GMP (2010 Revision), EU GMP Annex 1, US FDA cGMP, and ISO 14644 international standards.
Compliance is built into the design from the outset, ensuring smooth audits and certifications by domestic and international regulatory authorities.
Modular & Flexible
High-performance metal wall panel modular systems offer robust structure, excellent airtightness, enable rapid installation, and facilitate future modifications, expansions, or relocations.
Flexible layouts tailored to process flows (personnel, material, waste) support various production modes and future technological upgrades.
In-Depth Needs Analysis: Work closely with your production, quality, and R&D teams to thoroughly understand process requirements.
Concept & Preliminary Design: Provide Process Flow Diagrams (PFDs), room layouts, and people/material flow diagrams.
Detailed Design: Deliver full construction drawings (HVAC, electrical, plumbing, controls) and 3D BIM models for clash detection to avoid construction conflicts.
Phase 2: Construction & Management
EPC (Engineering, Procurement, Construction) Model: Single-point responsibility avoids multi-party disputes and ensures overall control of project schedule, cost, and quality.
Strict Quality Management System: Full auditing and documentation of materials, workmanship, and milestones.
Experienced Team: Project managers, engineers, and construction personnel have extensive experience in biopharmaceutical projects.
Phase 3: Testing & Certification
IQ/OQ/PQ Services: Provide complete Installation, Operational, and Performance Qualification documentation packages ensuring compliance with GEP and GMP.
Third-Party Certification: Assist in liaising with accredited third-party testing agencies for authoritative certification and reports.
Phase 4: Operation & Support
Training Services: Provide systematic training for your operation and maintenance staff.
Maintenance: Offer efficient preventive maintenance plans and spare parts support.
Upgrades & Retrofits: Provide future technology upgrade and facility modification plans based on existing systems.
FAQ
Q1: What is the approximate total investment for building a biopharmaceutical cleanroom?
A: Costs vary significantly based on cleanliness class, area, control precision (temp/RH/pressure), equipment selection (local/imported), and automation level. Typically, an ISO Class 5 (Grade A) area costs much more per square meter than an ISO Class 8 area. We recommend providing initial process requirements for a budgetary estimate.
Q2: How long does the entire project take from design to certification?
A: A mid-size project (500-1000㎡) typically takes 6-12 months. The exact timeline depends on design complexity, approval processes, equipment lead times, and site conditions. We develop a detailed Master Plan and share it with you for full transparency at every step.
Q3: Can your control system integrate data with my existing production equipment (e.g., fillers, lyophilizers)?
A: Absolutely. Our EMS/BMS systems use open protocols (e.g., OPC, Modbus) and have strong integration capabilities to communicate and integrate data with mainstream production equipment, SCADA, and MES systems, enabling a true "Smart Factory."
Q4: How is ongoing compliance ensured during operation?
A: Ongoing compliance relies on three pillars: 1) Reliable Hardware: We provide high-quality, stable infrastructure. 2) Robust Software: The EMS system enables continuous monitoring and data logging. 3) Scientific Management: We help you establish Standard Operating Procedures (SOPs) for gowning, cleaning/disinfection, environmental monitoring, preventive maintenance, and provide relevant training.
Q5: Do you provide validation (IQ/OQ/PQ) documentation services?
A: Yes, this is a core part of our service. We have a dedicated validation team that prepares and executes full validation documentation packages according to GAMP 5 guidelines, ensuring all documents meet GMP regulations and efficiently support your audits.