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Cleanroom Rental for Startups and Growing OEMs

Startups creating new medical devices and growing commercial OEMs requiring surge capacity can rent our Class 7 (Class 5 pharma) cleanroom space and equipment to build prototypes, small lots, or scale production, all while benefitting from LSO engineering staff support.

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Flexible Cleanroom Solutions to
Accelerate Innovation and Scale Production

Life Science Outsourcing offers Class 7 cleanroom rentals for startups and growing commercial OEMs requiring surge capacity. With a regulatory-ready environment and engineering support, our facilities provide the flexibility needed for prototyping, small-scale production, or scaling operations—allowing you to focus on delivering high-quality medical devices.

What is a cleanroom used for?

A cleanroom provides the necessary environment to bring new medical device innovations to life. The controlled environment, strict protocols, and continuous monitoring ensure that your new devices are compliant and safe for the end user.

Contamination control

Medical devices must meet strict sterility and cleanliness standards. Cleanrooms provide a controlled environment with low levels of pollutants (dust, airborne microbes, and aerosol particles) to prevent contamination during manufacturing.

Product integrity

Medical device integrity and functionality can be compromised by contamination, no matter how minimal. Cleanrooms help your products achieve the highest quality for patient safety and overall effectiveness.

Regulatory standards

The U.S. FDA and other regulatory bodies require that medical devices are manufactured in environments that control contamination risks. A cleanroom is often necessary to meet such regulatory requirements.

A cleanroom meets several important criteria to ensure patient safety, achieve regulatory approval, and make your products more competitive in the market.

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Who needs cleanroom rental?

Startups generally do not have space or cleanrooms to perform medical device sample production. That’s where Life Science Outsourcing can help. We’re committed to helping medical device manufacturers find the answers and solutions they need to bring their innovations to life quickly and efficiently. 

OEMs Seeking Surge Capacity

  • Immediate cleanroom access: Class 7 (Class 5 pharma) cleanroom space available for short-term production needs.
  • Scalable solutions: Manage seasonal demand or unexpected production surges with ease.
  • Cost-efficient flexibility: Avoid delays and high capital investments with flexible rental options.
  • Support for new launches: Perfect for accelerating new product introductions to the market.
  • Expert resources: Advanced tools and engineering expertise ensure consistent product quality.

Startups

  • Turnkey production space: Immediate access to Class 7 (Class 5 pharma) cleanrooms for prototypes or small-batch runs.
  • Regulatory-ready environments: Build under FDA-compliant conditions without costly investments.
  • Streamlined operations: Focus on innovation while we handle operational complexities.
  • Scalable as you grow: Adaptable solutions for transitioning from pilot runs to full production.
  • Guided expertise: Access to engineering staff to support your product development journey.

Research & Development Teams

  • Controlled environments: Conduct critical testing and feasibility studies in ISO-certified cleanrooms.
  • Short-term flexibility: Secure rental options tailored to R&D project timelines.
  • No minimum build requirements: Ideal for small-scale runs or early-stage prototypes.
  • Cost-effective experimentation: Avoid the need for long-term facility investments.
  • Streamlined workflows: Leverage cleanroom setups to maintain efficiency during clinical builds.
  • End-to-end support: Partner with experienced teams to ensure smooth project execution.

How does cleanroom rental work?

LSO can provide Class 10,000/ISO 7-rated cleanroom space to early-stage companies that may not be registered with the FDA or that do not have their own facilities. We provide an option to rent cleanroom space on a daily basis to build prototypes or small lots and use equipment and engineering staff to assist you in the early stages of product development.

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Why LSO?

With state-of-the-art facilities in California, New Hampshire and Costa Rica, Life Science Outsourcing supports over 125,000 total square feet of dedicated medical device manufacturing, assembly, packaging and sterilization space.

These sites include 12 total Class 5, 6, 7 and 8 cleanrooms, including a Class 7 dry room. Within these rooms are spaces dedicated to low-humidity manufacturing and solvent scouring for careful handling of bioabsorbable polymers.

Each site also features over 30,000 square feet of warehouse space with multiple shipping and receiving bays for flexible raw material and finished product staging.

Our medical device incubator services offer comprehensive support for medical device development, including facility utilization, quality management guidance, FDA registration assistance, clinical and R&D builds, full traceability, and product packaging and validation support

Full EtO Validation

Comprehensive packages for regulatory compliance.

Flexible Sterilization Cycles

From fractional to full cycles with EtO residual testing.

Robust Qualification

Secure with 2X qualification.

Choice of PCDs

Tailored to your sterilization needs.

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