We provide full-process clean piping construction services, including design, prefabrication, on-site welding, and testing:
| Service Stage | Content | Core Value |
|---|---|---|
| Piping Design | Process piping layout, slope design, and drainage point setting | Eliminate dead ends, meeting GMP requirements |
| Factory Prefabrication | Prefabrication of piping sections and pre-assembly of components in a clean room environment | Reduce on-site welding, improve quality control |
| On-site Welding | Automatic welding/manual welding, inert gas protection | Smooth welds, no oxidation, no contamination |
| Weld Inspection | Endoscope inspection, radiographic testing, passivation film testing | Ensure traceable weld quality |
| System Testing | Pressure test, airtightness test, cleanliness verification | Guarantee system delivery quality |
| Process | Application Scenario | Technical Features |
|---|---|---|
| Track Automatic Welding | Clean piping, sanitary piping, thin-walled piping | Programmable welding parameters, aesthetically pleasing weld formation, small heat-affected zone, high repeatability |
| Manual TIG Welding | Complex joints, non-standard pipe fittings, renovation projects | Flexible response to complex conditions, certified welders |
| Argon Gas Protection | Stainless steel piping welding | Backside argon protection to prevent oxidation, ensuring smooth inner surface of the weld |
| Micro-plasma Welding | Thin-walled pipes, precision pipe fittings | Low heat input, minimal deformation, suitable for thin-walled pipe welding |
Biological pharmaceutical piping welding follows strict industry standards and internal quality control:
| Control Stage | Standard Requirements | Verification Method |
|---|---|---|
| Welder Qualification | Qualified personnel, regular retraining | Qualification certificate, skill assessment records |
| Welding Procedure Qualification | Covers all pipe diameters, wall thicknesses, and materials | Welding procedure qualification report (PQR) |
| Inner Surface Quality of the Weld | No oxidation, no weld spatter, no cracks | Endoscope inspection, 100% coverage |
| Weld Roughness | Ra ≤ 0.4μm (optional higher requirement) | Roughness meter inspection |
| Weld Reinforcement | ≤ 10% of the pipe wall thickness | Visual inspection + measuring tools |
| Passivation Treatment | Complete passivation film on the weld area | Blue spot test |
| Application Field | Piping System | Welding Requirements |
|---|---|---|
| Water for Injection (WFI) System | 316L stainless steel, sanitary piping | Track automatic welding, 100% endoscope inspection, passivation treatment |
| Purified Water (PW) System | 304/316L stainless steel | Argon gas protection, smooth inner surface of the weld |
| Batch Preparation System | Sanitary piping, CIP/SIP piping | Dead-end-free design, slope meets requirements |
| Cell Culture System | Clean piping, sterile connection | Thin-walled pipe welding, heat-affected zone control |
| Purification and Chromatography System | Corrosion-resistant piping | Verification of corrosion resistance of the weld |
| Clean Steam System | Sanitary piping | High-temperature resistant weld, stress control |
| Guarantee Stage | Content |
|---|---|
| Material Traceability | Use pharmaceutical-grade stainless steels such as 316L and 304, with traceable material reports; brand of pipes and fittings can be specified |
| Welder Management | Qualified personnel, regular skill assessments, qualification records for key projects |
| Welding Records | Automatic welding parameter records, manual welding work records, fully traceable for each weld |
| Process Inspection | Pre-weld groove inspection, post-weld appearance inspection, endoscope inspection |
| Non-destructive Testing | Radiographic testing (RT), penetrant testing (PT), configured as needed |
| Document Delivery | Welding records, inspection reports, passivation reports, as-built drawings, meeting GMP validation requirements |
We assist our clients in completing the validation of the piping system, providing complete documentation:
| Validation Stage | Delivered Documents |
|---|---|
| Design Qualification (DQ) | Piping design drawings, material list, welding procedure specification |
| Installation Qualification (IQ) | Welder qualifications, welding records, endoscope inspection reports, pressure test reports |
| Operational Qualification (OQ) | System flushing records, passivation reports, cleanliness verification |
| Performance Qualification (PQ) | Support client in completing system performance testing |
| Advantages | Description |
|---|---|
| Professional Welding Team | Welders are qualified, with many years of experience in biological pharmaceutical clean piping welding |
| Advanced Welding Equipment | Equipped with track automatic welding machines, endoscopes, passivation inspection instruments, and other professional equipment |
| Strict Quality Control | Comprehensive quality control from pre-weld preparation to post-weld inspection |
| Complete Traceability System | Each weld can be traced back to the welder, process parameters, and inspection records |
| GMP Validation Support | Provide complete validation documents, assist clients in passing GMP inspections |
| Clean Construction | Prefabrication in clean rooms + on-site clean construction, ensuring piping cleanliness |
The welds are the key factor determining the cleanliness of the biological pharmaceutical piping system. Each weld is a commitment to drug safety.
HOFUTECH provides safe, reliable, and traceable clean piping welding construction services for the biopharmaceutical industry through professional welding technology, strict quality control, and a complete traceability system. We look forward to working with pharmaceutical companies and engineering firms to jointly safeguard life and health.