We design and produce packaging solutions suitable to be integrated in the pharmaceutical, food, chemical and cosmetic sectors.
All the processes involved in the development of our equipment are subject to the strictest international regulations and protocols for quality, hygiene and security to ensure that all our machines are apt to work into any industrial environment.
Regulations and Protocols applied
1. ISO 9001
ISO 9001 is the world's most widely recognized Quality Management System (QMS). It belongs to the ISO 9000 family of quality management system standards (along with ISO 9004), and helps organizations to meet the expectations and needs of their customers, amongst other benefits.
An ISO 9001 quality management system helps in continually monitor and manage quality across all operations, and outlines ways to achieve, as well as benchmark, consistent performance and service.
2. CE Marking
The CE marking (an acronym for the French "Conformite Europeenne") certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe. A manufacturer that has gone through the conformity assessment process, may affix the CE marking to the product. With the CE marking, the product may be marketed throughout the EU.
All our equipment is CE marked.
3. F.A.T. / S.A.T
FAT or Factory Acceptance Test is usually preformed at the vendor prior to shipping to a client. The vendor tests the system in accordance with the clients approved test plans and specifications to show that system is at a point to be installed and tested on site.
ISPE verdict: The partial commissioning and qualification of equipment and/or systems prior to their shipment from the fabricator’s site.
SAT is a Site Acceptance Test the system is tested in accordance to client approved test plans and specifications to show the system is installed properly and interfaces with other systems and peripherals in its working environment.
ISPE verdict: Inspection and /or dynamic testing of the systems or major system components to support the qualification of an equipment system conducted and documented at the manufacturing site.
GMP (Good Manufacturing Practices) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical or food production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
All our equipment is apt and suitable to obtain a GMP certificate.
IFS - International Food Standard
This is a private technical protocol developed by German, French and Italian distributors intended to help suppliers to supply safe products in accordance with specifications and current legislation.
This protocol requires the previous implementation of a quality management system, an HACCP system based on the Codex Alimentarius, as well as the implementation and management of prerequisites and facilities. It includes all the requirements governing suppliers and conforms to international GFSI requirements, giving a clear vision of concepts of food safety and quality control via assessments of suppliers, in which a complete view of their activity is provided.
All our equipment is apt and suitable to obtain a IFS certificate.
6. Equipment Qualification (DQ/IQ/OQ/PQ)
DQ/IQ/OQ/PQ protocols are ways of establishing that the equipment which is being used or installed will offer a high degree of quality assurance, so that manufacturing processes will consistently produce products that meet predetermined quality requirements.
Design Qualification (DQ)
The first element of the validation of new facilities, systems or equipment could be design qualification (DQ). The compliance of the design with GMP should be demonstrated and documented.
Installation Qualification (IQ)
Installation qualification (IQ) should be performed on new or modified facilities, systems and equipment. IQ should include, but not be limited to the following:
- installation of equipment, piping, services and instrumentation checked to current engineering drawings and specifications;
- collection and collation of supplier operating and working instructions and maintenance requirements;
- calibration requirements;
- verification of materials of construction.
Operational Qualification (OQ)
Operational qualification (OQ) should follow Installation qualification. OQ should include, but not be limited to the following:
- tests that have been developed from knowledge of processes, systems and equipment;
- tests to include a condition or a set of conditions encompassing upper and lower operating limits, sometimes referred to as “worst case” conditions. The completion of a successful Operational qualification should allow the finalization of calibration, operating and cleaning procedures, operator training and preventative maintenance requirements. It should permit a formal "release" of the facilities, systems and equipment.
Performance Qualification (PQ)
Performance qualification (PQ) should follow successful completion of Installation qualification and Operational qualification. PQ should include, but not be limited to the following:
- tests, using production materials, qualified substitutes or simulated product, that have been developed from knowledge of the process and the facilities, systems or equipment;
- tests to include a condition or set of conditions encompassing upper and lower operating limits.
Although PQ is described as a separate activity, it may in some cases be appropriate to perform it in conjunction with OQ.
Evidence should be available to support and verify the operating parameters and limits for the critical variables of the operating equipment. Additionally, the calibration, cleaning, preventive maintenance, operating procedures and operator training procedures and records should be documented.