A builder of automatic assembly systems must have proven know-how and experience in the profession, as well as the ability to excel in the details of the processes and production environment that is specific to medical devices. Although regulatory agencies (such as the FDA) have created a framework for product approval, very little has been done to regulate the choice of production technology. Ismeca has developed a machine process qualification procedure that anticipates our customers’ needs. All parts of our company and all project teams have been trained in the specific requirements of medical projects in order to guarantee both traceability and success.

• A quality system conforming to CFR 21 GMP 820. This establishes procedures and defines responsibilities for all of the internal processes at Ismeca (design, manufacturing, documentation and qualification).
• Know-how and experience in system qualification (DQ, IQ, and OQ) supplying documented proof that the system will provide reliable and robust production as per the specifications.
• Know-how and experience in engineering systems that conform to clean room conditions from class 100,000 to class 1000.
• Know-how and experience in aseptic system design
• Certification to ISO-9000 – 2000.
• Use of tools such as Design of Experiments (DOE) and Failure Mode and Effect Analysis (FMEA).

Modern medical and pharmaceutical devices have an ever-increasing number of components, and are often assembled through automation. These devices often require technology that goes beyond the traditional assembly processes of placing and pressing. Engineers must successfully manage six critical areas for a project to reach its goals: component feeding, component handling, process integration, work-in-process inspection, packaging and component origin data management during all stages of assembly.



1. Component Feeding :
   From bulk via vibratory or centrifugal feeders equipped with hoppers. From thermoformed or metal trays. From “on-line” manufactured components such as springs. From “packs” such as needles, including tip orientation.
   
   
2. Component Handling :
   Flexible tube coiling. High speed handling of several pieces simultaneously. Vision assisted parts handling, orientation, and assembly. Load cell assisted assembly or process operation. Assembly, corona treatment and bonding of needles. Servo motor assisted handling, orientation and assembly.
   
   
3. Processes integration :
   Volumetric dispensing of liquids. UV or thermo cured adhesives. Cyclohexane bonding. Ultrasonic welding. Laser bonding and welding. O-ring assembly. Spring assembly. Screw assembly. Riveting.
   
   
4. Identification :
   Labeling using ink-jet, self adhesive labels, laser marking, pad printing or other technologies. Work in Process Inspection.
   
   
5. Control :
   Contact and non-contact dimensional measurement. Shape, label or marking verification using high speed high resolution vision systems. Character recognition through vision systems. Flow or leak checking (helium, air and other liquids). Weight verification. Force or resistance measurement. Electrical resistance, continuity or other tests.
   
   
6. Packaging : To trays for transfer to downstream operations. To form, fill, and seal systems. To bagging systems. To cartons or other type of containers. Component Origin Data Management. Via temporary bar coding, 2D matrix, or alpha numeric characters. Via Ink jet or laser based impressions. Interfacing with a host ERM or ERP system.

Customers insist upon having equipment that makes defect free products and is available 24 / 7, as well as conforming to the norms and regulations in force for the region in which the system is installed. Conformity with CE directives (98/37CE Machines, 89/336/CCE and 92/31/CEE for electromagnetic compatibility, 73/23/CEE low voltage) is part of our internal specification and is guaranteed for all our systems. Ismeca is ISO 9000-2000 certified and our quality system is compatible with 21 CFR 820 (GMP).

Our systems are engineered to conform to all regulations concerning contact materials, as well as cleaning accessibility. The use of compressed air and systems requiring any type of lubrication is kept to a strict minimum. Stainless steel is used extensively for system guarding and other critical surfaces.

Certain systems can be engineered compatible with aseptic conditions and thus certain operations such as the filling of active products can be integrated into a line. As far as operator security is concerned, risk analysis is carried out at the start of each project to ensure all the necessary safeguards are put into place.

Customers require production systems that deliver flawless outputs that are available 24/7 and respect the constraints of your product and the relevant regulations. Ismeca are certified to ISO 9001-2000 and oriented towards GMP 820. By design, our systems respect your needs in terms of material choices and access for cleaning. The use of compressed air and lubricants is kept to a strict minimum stainless steel is used extensively, even for safety guards.

Aseptic design, whether for a complete system or only for limited sections, is part of our expertise and the filling of active products can be integrated into an Ismeca line.

Finally, and most importantly, operator safety is assured for every system through a CE compliant risk analysis carried out at the beginning of each project to ensure all necessary measures are put into place.

• extensive study of possible failures and errors which may occur
• an identification of the most critical elements
• definition of the preventive actions to be taken
• selection of the technology best adapted to the situation

The goal of IQ documentation is to guarantee that the system tested conforms to both the documentation produced which is approved by the customer and the system specification.

IQ documentation is all produced on site at Ismeca. Once installed at the customer’s facility, it is strongly recommended that an IQ be repeated.

Any change to the system that can influence the product requires a re-qualification. In the absence of changes, re-qualifications are carried out every 5 years.

A detailed qualification protocol covering every step in the process is established. An IQ test sheet documenting all the details of the actual qualification is filed in section 7 of the system IQ file.

Energy requirements as well as relevant physical characteristics of the system (floor loading, working temperature ranges, dimensional data, etc.) are also noted in this document.

IQ test sheets and associated documents

• Complete verification of the quality of documentation.
• Vision system software documentation (if present).
• Screen layout documents for the vision system (if present).
• Overall installation inspection.
• Machine risk analysis according to established documents.
• Verification of system layout.
• Verification of mechanical systems.
• General parts list (complete).
• Spare parts list.
• Master drawing list.
• Detail drawings of all project specific elements.
• List of all vision based measurement systems.
• List of all test systems complete with relevant certificates.
• Specification and User Guide for all OEM materials.
• Electrical wiring inspection.
• Mechanical adjustment inspection.
• CE conformance documentation (with the results of tests EN 60204, EMC, and noise level measurements), electrical and compressed air consumption data.
  
  OQ Test Sheets and Associated Documents
  
• Software Validation.
• Tests carried out.
  • I/O verification.
  • Menu verification.
  • Software check list (CAQ 1082) .
  • Grafcet.
  • Validation run files.
• Subsystem validation (if present).

OQ documentation establishes written proof that the system conforms to the functional requirements of the Technical Specification agreed, and to the approved technical documents associated with the project, and this within all foreseeable circumstances.

OQ documentation is carried out in its totality at the Ismeca factory by our own personnel. Once installed at the production site, OQ is usually repeated.

Any change to the system that can influence the product requires a partial or total re-qualification. In the absence of changes, re-qualifications are carried out every 5 years.

A detailed qualification protocol covering every step in the process is established. An OQ test sheet documenting all the details of the actual qualification is established. A system specification, including a software specification is supplied.

Medical Applications