Leveraging its expertise in precision machinery and automation, Zhejiang Guoyu delivers ‌high-cleanliness, compliance-driven, and reliable process equipment and solutions‌ for the pharmaceutical industry, covering ‌solid dosage forms (tablets/capsules/granules), liquid formulations, biologics, active pharmaceutical ingredients (APIs), and medical devices‌. The company supports clients in meeting GMP standards, data integrity (ALCOA+ principles), and global certification requirements. Below are its core applications and technological strengths in this sector:

‌1. Core Application Scenarios‌

‌a. Solid Dosage Manufacturing (Tablets/Capsules/Granules)‌

‌•‌High-Potency API (HPAPI) Handling‌:

- Containment isolators (OEB Level 5) with integrated filling systems, featuring HEPA filtration and negative pressure control for operator safety.

- Weighing accuracy ±0.1%, enabling precise dosing of micro-active ingredients.

‌•‌Cross-Contamination Prevention‌:

- Modular production lines support rapid product changeovers. CIP/SIP systems ensure cleaning residues <1ppm, complying with EMA/FDA validation standards.

‌b. Liquid Formulations and Biologics‌

‌‌•Aseptic Filling (BFS/Vials)‌:

- Isolator-based aseptic filling lines (ISO Grade 5) for vaccines, monoclonal antibodies, etc., with ±0.2% filling accuracy.

- In-process particle monitoring and container-closure integrity testing (CCIT).

‌•High-Viscosity Drug Solutions‌:

- Servo-driven piston pumps and heated pipelines for syrups, gels, etc., minimizing bubble formation.

‌c. API Production‌

‌‌•Closed Transfer and Packaging‌:

- Bag-in/bag-out (BIBO) technology to prevent dust exposure, meeting OEB Level 3-4 requirements.

- Inert gas protection systems to reduce oxidation risks during API handling.

‌d. Medical Device Packaging‌

‌‌•Aseptic Medical Device Filling‌:

- Automated liquid filling and heat-sealing lines for pre-filled syringes, catheter flush solutions, etc., with residual oxygen control <0.1%.

‌2. Technological Advantages‌

‌a. Compliance and Data Integrity‌

‌•‌GMP-Compliant Design‌:

- Smooth, crevice-free surfaces with USP Class VI and ASME BPE-certified materials.

- Electronic record systems (SCADA/MES integration) compliant with 21 CFR Part 11 traceability requirements.

‌•‌Process Analytical Technology (PAT)‌:

-Real-time monitoring of pH, conductivity, and weight to adjust process parameters, reducing batch variability.

‌b. Aseptic and Containment Technologies‌

‌•‌RABS/Isolator Systems‌:

- Grade A laminar airflow protection in critical filling zones, with dynamic environmental monitoring (particles, microbes).

‌- Single-Use Technology (SUT) Compatibility‌:

- Supports disposable bags and tubing, minimizing cleaning validation efforts.

‌c. Efficiency and Sustainability‌

‌‌•Continuous Manufacturing (CM)‌:

- Modular designs enable end-to-end production from blending to filling, reducing intermediate storage risks.

‌‌•Energy Optimization‌:

- Variable-frequency drives and heat recovery systems reduce overall energy consumption by 25%.

‌3. Client Case Studies‌

‌‌•Global Biopharma Company‌: Deployed a BFS aseptic filling line achieving 6,000 units/hour, passing FDA inspections.

‌‌•Leading Traditional Chinese Medicine Manufacturer‌: Customized closed granule packaging line reduced cross-contamination risks by 90%, securing updated GMP certification.

‌‌•CMO (High-Potency APIs)‌: OEB Level 5 containment system safely processes >50 tons of toxic APIs annually with zero operator exposure incidents.

‌4. Value-Added Services and Global Support‌

‌•‌Validation Services (IQ/OQ/PQ)‌: Full documentation packages (URS/DQ/FAT/SAT) to accelerate project timelines.

‌‌•Multinational Compliance‌: Assistance with NMPA (China), FDA (USA), EMA (EU), and other regional regulations.

‌‌•Smart Maintenance‌: Predictive maintenance via IIoT, with global critical spare parts delivery within 48 hours.

‌Summary‌: Zhejiang Guoyu combines ‌“sterility assurance + data-driven control + flexible compliance”‌ to deliver end-to-end solutions for pharmaceutical R&D and commercial production. Its innovations help clients navigate complex regulations, enhance productivity, and mitigate quality risks, positioning the company as a strategic partner for pharmaceutical modernization and global expansion.