Pharmaceutical & Food Clean Vacuum Solutions

Q: What is ISO 8573‑1 Class 0, and why is it important for pharmaceutical vacuum systems?

ISO 8573‑1 Class 0 is the highest standard for compressed air and vacuum purity, indicating zero measurable oil content (both liquid oil, oil aerosol, and oil vapor). For pharmaceutical manufacturing, oil contamination can ruin batches, cause product recalls, and violate GMP regulations. Class 0 certification provides documented assurance that the vacuum system will not introduce hydrocarbons. Our dry pumps are independently tested and certified to Class 0, and we provide the certificate as part of the validation package.

Q: Do you provide validation documentation for FDA inspections?

Yes. We provide a complete validation package including: IQ (Installation Qualification) and OQ (Operational Qualification) protocols with test scripts, material certificates (3.1 EN 10204) for wetted parts, surface finish reports (Ra measurement), weld maps, and FAT/SAT test reports. For 21 CFR Part 11 compliance, we offer software with audit trails, user role management, and electronic signatures. Our documentation is reviewed by your QA team before shipment. We also support PQ (Process Qualification) if required.

Q: Can the vacuum system be cleaned in place (CIP) without disassembly?

Yes. For hygienic applications, we design the vacuum piping and chamber with CIP spray balls and sanitary connections. The pump itself is not typically CIP‑able (except for specialized liquid‑ring pumps), but we isolate the pump during CIP cycles using hygienic valves. The system can be programmed to run a CIP sequence with hot water, cleaning solution, and rinse, followed by drying under vacuum. We provide CIP validation support including residue testing protocols.

Q: What is the difference between a dry scroll pump and a dry claw pump for food applications?

Dry scroll pumps are best for small to medium flow rates (5–40 m³/h) and are very quiet (48–55 dB(A)). They are ideal for laboratory, tablet press dust extraction, and small conveying systems. Dry claw pumps handle higher flow rates (100–400 m³/h) and are more tolerant of particulates and moisture. They are preferred for central vacuum systems, large freeze‑dryers, and continuous powder conveying. Both are ISO 8573‑1 Class 0 certified. We recommend scroll for lab/benchtop, claw for industrial production lines.

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In pharmaceutical manufacturing and food processing, vacuum systems must not become contamination sources. AIMRSE delivers clean vacuum solutions designed for GMP, FDA, and EHEDG requirements. Our systems feature oil‑free dry pumps (ISO 8573‑1 Class 0), electropolished stainless steel chambers, and hygienic piping with no dead legs. Options include CIP (clean‑in‑place) and SIP (steam‑in‑place) compatibility, HEPA exhaust filters, and full 21 CFR Part 11 data logging for batch traceability. Ideal for vacuum conveying, tablet press dust extraction, freeze‑drying, and packaging. Each system is supplied with IQ/OQ validation protocols, material certificates, and surface finish reports. Explosion‑proof configurations available for solvent‑based processes. Supported by US‑based service and compliance documentation for regulatory audits.

Consult Our Clean Vacuum Specialists

Discuss your GMP requirements, cleaning protocols, and validation needs — we'll propose a compliant vacuum solution.

IQ/OQ validation packages, 21 CFR Part 11 ready, US‑stocked spare parts

Pharmaceutical & Food Clean Vacuum Priorities

Oil‑Free & Particle‑Free Operation

ISO 8573‑1 Class 0 certified dry pumps. No oil mist, no hydrocarbon contamination. HEPA exhaust filters for critical areas.

Hygienic Design & Cleanability

316L stainless steel, electropolished to Ra ≤ 0.4 µm. No dead legs, sanitary flanges, and CIP/SIP compatibility for easy cleaning.

GMP Compliance & Data Integrity

21 CFR Part 11 electronic records, audit trails, and batch logging. IQ/OQ validation packages included. Full material traceability.

Clean Vacuum System Engineering Workflow

From GMP requirement analysis to validated system — fully documented.

GMP Requirement Analysis

Define cleanliness class, validation level, and regulatory standards (FDA, EU GMP, EHEDG).

Hygienic Design & Material Selection

316L stainless steel, electropolishing, sanitary flanges, and CIP spray ball integration.

Dry Pump & Filtration Selection

Choose scroll or claw pump, HEPA exhaust filter, and inlet filter grade.

Validation Documentation

Generate IQ/OQ protocols, material certs, surface finish reports, and FAT plan.

Factory Acceptance & Installation

FAT at our facility, on‑site SAT, and IQ/OQ execution with your QA team.

Training & Ongoing Support

Operator training on CIP/SIP cycles, filter replacement, and data log review.

The Advantages of AIMRSE

GMP‑ready, hygienic, and fully validated — engineered for regulated industries.

ISO 8573‑1 Class 0 Certified

100% oil‑free dry pumps. No hydrocarbon contamination. HEPA exhaust filters for critical areas.

Hygienic Design & CIP/SIP Ready

316L stainless steel, electropolished Ra ≤ 0.4 µm. Sanitary clamps, no dead legs. CIP spray balls and SIP compatibility available.

21 CFR Part 11 & Data Logging

Electronic records, audit trails, and batch reporting. Secure user authentication. IQ/OQ validation protocols included.

Validation & Documentation

Material certs (3.1), surface finish reports, FAT/SAT protocols, and spare parts kits. US‑based service and calibration.

Clean Vacuum Success Stories

Real improvements in contamination control, validation, and uptime.

Tablet Press Dust Extraction System

New Jersey, USA

A pharmaceutical manufacturer needed a clean vacuum system for tablet press dust extraction. AIMRSE supplied an oil‑free dry scroll pump with HEPA exhaust filter and stainless steel piping. The system eliminated oil mist contamination and passed FDA inspection. Particle capture efficiency exceeded 99.9%, and the pump operates quietly (<55 dB(A)) on the production floor.

Freeze‑Dryer Vacuum Upgrade

Iowa, USA

A vaccine manufacturer replaced oil‑sealed pumps on their freeze‑dryers with AIMRSE dry claw pumps and cold traps. The oil‑free pumps eliminated product contamination risk. The system includes 21 CFR Part 11 data logging of pressure and temperature. Validation was completed in two weeks, and the pumps have run 24/7 for 18 months with no oil‑related downtime.

Food Powder Vacuum Conveying System

Kansas, USA

A food ingredient plant needed a hygienic vacuum system for conveying powdered milk. AIMRSE supplied a dry claw pump with a sanitary inlet filter, 316L electropolished piping, and CIP spray balls. The system is EHEDG compliant and can be cleaned without disassembly. Cross‑contamination between batches is eliminated, and the pump runs quietly in the production area.

Customer Reviews

Real feedback from quality assurance managers and plant engineers.

L**am B.

★★★★★

"We installed AIMRSE's oil-free dry scroll vacuum system for tablet press dust extraction in our pharmaceutical plant. It comes with HEPA exhaust filtration and 316L stainless steel hygienic piping, reaching over 99.9% particle capture efficiency. The system completely eradicated oil mist contamination, passed FDA inspection successfully, and runs quietly below 55 dB(A) on the production floor."

E**la K.

★★★★★

"Our vaccine manufacturing factory upgraded freeze-dryer vacuum systems with AIMRSE dry claw pumps and cold traps. These oil-free devices eliminated all product contamination risks, and the built-in 21 CFR Part 11 data logging guarantees complete batch traceability. Validation was completed in only two weeks, and the pumps have operated 24/7 for 18 months with no oil-related downtime."

Technical FAQ

What is ISO 8573‑1 Class 0, and why is it important for pharmaceutical vacuum systems?

ISO 8573‑1 Class 0 is the highest standard for compressed air and vacuum purity, indicating zero measurable oil content (both liquid oil, oil aerosol, and oil vapor). For pharmaceutical manufacturing, oil contamination can ruin batches, cause product recalls, and violate GMP regulations. Class 0 certification provides documented assurance that the vacuum system will not introduce hydrocarbons. Our dry pumps are independently tested and certified to Class 0, and we provide the certificate as part of the validation package.

Do you provide validation documentation for FDA inspections?

Yes. We provide a complete validation package including: IQ (Installation Qualification) and OQ (Operational Qualification) protocols with test scripts, material certificates (3.1 EN 10204) for wetted parts, surface finish reports (Ra measurement), weld maps, and FAT/SAT test reports. For 21 CFR Part 11 compliance, we offer software with audit trails, user role management, and electronic signatures. Our documentation is reviewed by your QA team before shipment. We also support PQ (Process Qualification) if required.

Can the vacuum system be cleaned in place (CIP) without disassembly?

Yes. For hygienic applications, we design the vacuum piping and chamber with CIP spray balls and sanitary connections. The pump itself is not typically CIP‑able (except for specialized liquid‑ring pumps), but we isolate the pump during CIP cycles using hygienic valves. The system can be programmed to run a CIP sequence with hot water, cleaning solution, and rinse, followed by drying under vacuum. We provide CIP validation support including residue testing protocols.

What is the difference between a dry scroll pump and a dry claw pump for food applications?

Dry scroll pumps are best for small to medium flow rates (5–40 m³/h) and are very quiet (48–55 dB(A)). They are ideal for laboratory, tablet press dust extraction, and small conveying systems. Dry claw pumps handle higher flow rates (100–400 m³/h) and are more tolerant of particulates and moisture. They are preferred for central vacuum systems, large freeze‑dryers, and continuous powder conveying. Both are ISO 8573‑1 Class 0 certified. We recommend scroll for lab/benchtop, claw for industrial production lines.

Featured Solutions

Note: Our vacuum equipment is for research and industrial testing only. Industrial-grade components are fully rated for field deployment.

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Pharmaceutical & Food Clean Vacuum Solutions

Consult Our Clean Vacuum Specialists

Pharmaceutical & Food Clean Vacuum Priorities

Oil‑Free & Particle‑Free Operation

Hygienic Design & Cleanability

GMP Compliance & Data Integrity

Clean Vacuum System Engineering Workflow

The Advantages of AIMRSE

ISO 8573‑1 Class 0 Certified

Hygienic Design & CIP/SIP Ready

21 CFR Part 11 & Data Logging

Validation & Documentation

Clean Vacuum Success Stories

Tablet Press Dust Extraction System

Freeze‑Dryer Vacuum Upgrade

Food Powder Vacuum Conveying System

Customer Reviews

L**am B.

E**la K.

Technical FAQ

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