Contract Manufactured Medical Devices:

We source components, assemble, test, package, sterilize, stock and ship many types of devices used in a wide variety of medical markets including:

• Wound Care
• Ophthalmic
• Disposables
• Fixation

Our personnel are skilled in assembling products of varying complexity. We can manufacture products ranging from simple tubing sets, ultra-precision devices, wound care, ophthalmic products and more, that require pharmaceutical production equipment.

Manufacturing Process
Medical Device Manufacturing Processes:

With our average employee having over 20 years experience in medical device manufacturing, we are very well rounded in assembly techniques and methodologies. Our capabilities include design, manufacture and assembly and test equipment. We can assist with product design when desired. Our machine shops can fabricate prototypes that includes stereo lithography (SLA) versions from 2D or 3D files.

Assembly
Assembly Processes:

• Plastic part design
• Plastics injection molding
• Plastics assembly

Packaging
Packaging Processes:

Properly designed packaging will get your products to your customer intact and in optimal presentation with little cost. Improperly selected packaging can be very expensive and potentially severely delay a new product release. We can assist in all aspects of packaging selection and design. We utilize a variety of suppliers who can deliver quality materials, on time and as a low cost solution. Ceutical Laboratories will arrange approved transit testing for your product as requested.All of our packaging equipment is fully validated and incorporates total process controls. We routinely validate and monitor package seals using constrained burst testing, dye penetration and peel strength methods.

Sterilization
Sterilization:

Ceutical Laboratories, Inc. coordinates all aspects of sterilization including sterilization validations, quarterly dose audits, annual ETO re-qualifications and routine processing. We use only ISO certified processors and provide a certificate of processing with each shipment. We can help you select materials for your products which will allow you to use a preferred method of sterilization. Our ethylene oxide sterilizer is a renowned world wide expert.

Facilities
Quality System:

We are proud of our quality system. We firmly believe that Quality System Regulation and ISO standards establish the best business practices organization.Our system is designed to allow easy integration into or in conjunction with our customer’s systems. We assist our clients by helping to establish a quality system which is right for their business.

Design Control / Clinical Trials
Design Control:

Ceutical Laboratories, Inc. frequently produces product for our customer's clinical trials. We can adapt our capability to meet your needs. As design control is one of the elements of our quality system, we can provide significant guidance and assistance as we work through this element of the development process. Ceutical Laboratories can assist in writing marketing specifications, product specifications, validation protocols, assembly procedures, and packaging specifications. We can also prepare component drawings, design labeling, design tooling and fixtures, perform risk analysis, facilitate failure modes effect analysis (FMEA), conduct first article inspections, carry out product validations, coordinate sterilization validation and structure and compile the design dossier.

♦ Design Development
♦ Regulatory Submissions
♦ Process Development
♦ Manufacturing
♦ Online Technology
♦ Quality Management