Additional Information:

Package Validation

Situation: "What are the steps necessary in a package validation to comply with the FDA requirements?"

Solution:
LIFE SCIENCE OUTSOURCING will evaluate your product/package, write the validation protocol, specify sample requirements, provide complete testing services using its in-house ISTA certified test laboratory and issue a final report ready for submission to the appropriate regulatory body. LIFE SCIENCE OUTSOURCING can also perform tests designed to determine if your package design is adequate BEFORE the validation process is started.

In-house capabilities include:

Assembly

Situation: "We are not yet registered with the FDA as a medical device manufacturer. We need a licensed facility to build our clinical units."

Solution:
LIFE SCIENCE OUTSOURCING offers the following assembly services:

Packaging

Situation: "Our product is used in the O.R. I am not sure if we need a double sterile pouch design or if we should just package it in a tray with a tyvek lid".

Solution:
Life Science Outsourcing offers the following Packaging services

Sterilization

Situation: "We have a couple of products that may require different types of sterilization."

Solution:
LIFE SCIENCE OUTSOURCING offers the following sterilization services

Sterilization Validation

Situation: Due to the variety of materials used in our device, we need some assistance in choosing the right sterilization method for our product.

Solution:
LIFE SCIENCE OUTSOURCING will help you evaluate and choose the sterilization and validation method best suited to your product, write the appropriate validation protocol and submit it for your approval. Once approved, LIFE SCIENCE OUTSOURCING can handle all required testing and sterilization activities and will provide a complete final report. Life Science Outsourcing handles all required annual re-validations or quarterly dose audits.

LIFE SCIENCE OUTSOURCING provides:

Onsite Steam Sterilization

Situation: "We have been looking for a contract manufacturer that can fulfill our steam sterilization needs on a timely basis."

Solution:
LIFE SCIENCE OUTSOURCING provides contract steam sterilization services for any product capable of withstanding high-temperature sterilization. Our sterilizer features a high capacity 19 cubic foot chamber size.

We can program any desired cycle parameters and duplicate an existing sterilization cycle or develop a cycle for specialized requirements.

Sterilization validations are performed according to ANSI/AAMI/ISO guidelines. Our staff will prepare the protocol, perform all required sterilization cycles, conduct all testing and generate a complete final report. Customers review and approve the protocol before the validation process begins.

In addition to the sterilization processing, LIFE SCIENCE OUTSOURCING can package the product in heat-sealed pouches prior to sterilization and/or place the sterile product in unit cartons or master shippers, label the product, etc., so that the product is ready to distribute when it arrives at your facility.

Laboratory Testing

Situation: "I think that our product will require rigorous biocompatibility testing as part of our regulatory submission. Can you help us with the selection of testing?"

Solution:

Life Science Outsourcing offers the following Laboratory Testing services:

Regulatory / Quality

Situation: "We are an early stage company and do not fully understand the complexities of the regulatory / quality processes that we must undertake."

Solution:

Life Science Outsourcing offers the following Regulatory and Quality Services:

Package Validation

Situation: "What are the steps necessary in a package validation to comply with the FDA requirements?"

Solution:
LIFE SCIENCE OUTSOURCING will evaluate your product/package, write the validation protocol, specify sample requirements, provide complete testing services using its in-house ISTA certified test laboratory and issue a final report ready for submission to the appropriate regulatory body. LIFE SCIENCE OUTSOURCING can perform tests designed to determine if your package design is adequate BEFORE the validation process is started.

In-house capabilities include:

Life Science Outsourcing, Inc. is an FDA registered, ISO certified, full service Medical Device Contract Manufacturer, located in Orange County, CA. LIFE SCIENCE OUTSOURCING offers turnkey outsourcing solutions to both the Medical Device and Biopharmaceutical Industries.

LIFE SCIENCE OUTSOURCING has successfully served the medical device industry for the last ten years from their 56,000 square foot facility located in Brea, CA. The company has provided a home for many start-up and early stage Medical Device companies from across the country.

One of the key features that set LIFE SCIENCE OUTSOURCING apart from competitors is their ability to provide a competitive quotation for services on a timely basis. The company's reputation to successfully execute a project and provide consistent manufacturing repeatability is second to none. Contact LIFE SCIENCE OUTSOURCING to discuss your needs and their expansive list of services.

LSO's list of Contract Manufacturing Services include:

Categories this company is listed under in the North American Suppliers Directory:

• Contract Manufacturing and Packaging Services: Company Features: Class 10,000 Cleanroom Capabilities (488 companies)
• Contract Manufacturing and Packaging Services: Company Features: Electromedical Contract Manufacturer (441 companies)
• Contract Manufacturing and Packaging Services: Company Features: FDA Registered (582 companies)
• Contract Manufacturing and Packaging Services: Contract Services: Assembly (1413 companies)