One of the key elements to the introduction of any new product is the design engineering to ensure that the new product idea can be manufactured in a safe and cost effective manner. CeutiPak has obtained high caliber design engineers to enhance your designs and capabilities.

The types of products that our clients have brought to us are wide and varied. These products have included ophthalmics, nasal inhalation systems, drug delivery systems, fixation devices, surgical instruments, gynecological instruments, and wound care.

The principles of design are provided in ISO and QSR documentation and guidance. CeutiPak takes a six phase approach to its design control. Beginning with concept and ending with product transfer to the manufacturing facility. Each phase of the development process has established deliverables. These deliverables are mutually agreed and no advancement to the next level can occur without approvals of all parties.

During design and development for a new product, the client participates only at a level that is comfortable. CeutiPak can handle the entire project or participate in a limited fashion. Design reviews can require full participation of the customer or again can be handled without customer participation. The final design review and design approval will require customer approval.

Our design focus in on the end customer with significant concerns applied to the customer and manufacturing. The concerns applied to manufacturing include costs of process, cost of raw materials, and cost of equipment.

We look forward to participating in a design project with you.

CeutiPak has experienced personnel to assist in the development of parenteral, topical, and oral dosage forms. We can develop and fully document the entire production process. We have developed many products across most therapeutic classes.

Our Development Team Can:

• Develop and validate analytical techniques for measuring concentrations of active ingredients and excipients

• Establish formulation procedures, precautions and controls that support a wide variety of formulation approaches

• Establish formulation procedures for parenterals, whether aseptically filled or terminally sterilized

• Perform stability studies according to current ICH guidelines in temperature-controlled storage areas to establish product shelf life

• Match drug, excipient and solvent systems with various filtration media to attain maximum compatibility and efficiency

• Establish validation procedures for manufacturing processes

• Evaluate container/closure systems to select those best suited as determined by product compatibility, reconstitution allowance, and batch size

• Provide for orderly scale-up to full production volume to assure that the product can be manufactured efficiently. Many dosage forms have been developed and produced for both domestic and international markets. As a result, our analytical services include the testing specified in international pharmacopeias.

We assemble, test and package many types of 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 to ultra-precision devices to wound care to ophthalmic products 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

Flow and leak testing

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:

CeutiPak LLC. 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 help our clients by establish a quality system which is right for their business.

Design Control / Clinical Trials

Design Control:

CeutiPak LLC. 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. CeutiPak 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.