Pharmaceutical & Biotech
The pharmaceutical and biotech manufacturing sector operates under the most stringent quality and safety standards globally. Every stage of drug production, from API synthesis to final packaging, demands absolute contamination…
Understanding Your Industry
The pharmaceutical and biotech manufacturing sector operates under the most stringent quality and safety standards globally. Every stage of drug production, from API synthesis to final packaging, demands absolute contamination control and regulatory compliance. Manufacturing environments must maintain ISO Class 5-8 cleanroom standards while ensuring product purity meets FDA, EMA, and GMP requirements.
Modern pharmaceutical facilities face increasing pressure to eliminate all potential contamination sources while maximizing production efficiency. The shift toward biologics and sterile injectables has intensified the need for oil-free vacuum and compressed air systems. Traditional oil-lubricated equipment poses unacceptable risks of product contamination, regulatory violations, and costly production shutdowns.
Environmental sustainability has become equally critical, with pharmaceutical companies committed to reducing energy consumption and carbon emissions. Advanced process equipment must deliver reliable performance while meeting ESG targets and operating cost reduction goals. The integration of Industry 4.0 technologies requires vacuum and compression systems with intelligent monitoring, predictive maintenance capabilities, and seamless connectivity to building management systems.
Key Industry Requirements
Oil-free operation meeting ISO 8573-1 Class 0 certification
Full compliance with FDA 21 CFR Part 11 and EU GMP Annex 1
Cleanroom compatibility with minimal particle generation
Automated CIP/SIP validation protocols
Energy efficiency exceeding 30% vs conventional systems
Real-time monitoring with 21 CFR Part 11 data integrity
Real-World Applications
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Critical Pain Points
Understanding the challenges that impact your operations
Oil Contamination Risk
Traditional oil-lubricated vacuum pumps introduce petroleum-based contaminants into manufacturing processes, leading to batch rejection, regulatory non-compliance, and potential patient safety issues. Even trace oil contamination can compromise API purity and require costly remediation procedures.
Validation & Compliance Burden
Oil-based systems require extensive and frequent revalidation cycles, consuming significant resources and production downtime. Documentation requirements for oil changes, filter replacements, and contamination monitoring create substantial administrative overhead that diverts focus from core manufacturing operations.
High Operating Costs
Conventional vacuum pumps consume excessive energy due to inefficient oil cooling systems and constant lubrication needs. Frequent oil changes, filter replacements, and disposal costs significantly increase total cost of ownership. Unplanned downtime for maintenance disrupts production schedules and reduces facility utilization rates.
Environmental & Safety Concerns
Oil mist emissions, hazardous waste disposal, and energy inefficiency conflict with pharmaceutical companies' sustainability commitments. Workplace exposure to oil vapors poses health risks to operators, while accidental oil spills create environmental hazards requiring specialized cleanup and reporting procedures.
Our Advanced Solution
Engineered specifically for your industry requirements
Shichang’s oil-free screw vacuum pump and blower systems deliver pharmaceutical-grade performance through advanced dry screw technology. Our KZB and SCRV series eliminate all oil contamination risks while providing superior reliability and energy efficiency compared to conventional equipment.
The proprietary screw rotor design achieves ISO 8573-1 Class 0 certification without requiring filtration or downstream purification. Precision-machined components operate with minimal clearances, generating deep vacuum levels while consuming up to 42% less energy than oil-sealed alternatives. Integrated variable frequency drives automatically adjust motor speed to match real-time demand, optimizing power consumption across varying process loads.
All systems feature pharmaceutical-compliant materials with electropolished stainless steel contact surfaces and FDA-approved seals. Automated monitoring systems provide continuous data logging for validation documentation, with secure data storage meeting 21 CFR Part 11 electronic record requirements. Modular design enables rapid maintenance without process contamination, while predictive diagnostics minimize unplanned downtime and extend equipment service life.
Key Features & Advantages
100% Oil-Free Operation
Dry screw technology eliminates all petroleum contamination risks, ensuring pharmaceutical-grade air quality without filtration. ISO 8573-1 Class 0 certification guarantees zero oil carry-over into critical manufacturing processes, protecting product purity and regulatory compliance.
FDA & GMP Compliant Design
Pharmaceutical-grade materials with electropolished stainless steel surfaces prevent particle generation. Integrated data logging and validation protocols satisfy FDA 21 CFR Part 11 requirements, streamlining regulatory documentation and audit preparation.
42% Energy Reduction
Variable frequency drive technology and optimized screw profiles deliver exceptional energy efficiency. Intelligent load-matching automatically adjusts motor speed to process demands, significantly reducing electricity consumption and operating costs compared to fixed-speed oil-sealed pumps.
Minimal Maintenance Requirements
Oil-free design eliminates scheduled oil changes, filter replacements, and contamination monitoring. Extended service intervals and simplified maintenance procedures reduce downtime, lower operating costs, and allow personnel to focus on core manufacturing activities.
Cleanroom Compatible
Low vibration design and minimal particle generation enable installation within controlled manufacturing environments. Compact footprint and quiet operation integrate seamlessly into pharmaceutical facilities without compromising cleanroom classification or operator comfort.
Predictive Diagnostics
Industry 4.0 connectivity provides real-time performance monitoring and predictive maintenance alerts. Remote diagnostics and automated reporting reduce service costs while maximizing equipment uptime and production reliability.
Performance Comparison
Shichang solution vs. conventional alternatives
| Parameter | Traditional | Shichang |
|---|---|---|
| Energy Efficiency | 75% | 92% |
| Maintenance Frequency | Monthly | Quarterly |
| Oil Contamination Risk | High | Zero |
| Compliance Validation | Extensive | Automated |
| Service Life | 3-5 years | 8-10 years |
| Downtime/Year | 120+ hours | <24 hours |
See Our Solutions In Action
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KZB 3D Animation Demonstration
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Proven improvements your business will experience with data-driven insights
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