USE AND MAINTENANCE MANUALS AND TRANSLATIONS INTO ALL LANGUAGES
PHARMACEUTICAL VALIDATIONS AND TECHNICAL REGULATIONS
DRAWINGS, PRINTING AND LABELLING
MANUALS
We produce technical editing following prearranged directions and regulations, through a high-level graphic aspect and exalting to its most not only the publication but also the image of the manufacturer.
In co-operation with the manufacturers, REDIMEC carry out surveys on the machines and risk analysis, and therefore proceed to draft the technical booklet according to the referring regulations.
We carry out:
The exclusive internal management of the documents safeguards customers from the spreading of confidential information.
Phone us or send us an e-mail, after a first technical survey, we forward to you a free quotation!
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TRANSLATIONS
Communication has always been our work and our passion. Every word translated by us must transmit to those who read it in any part of the world the same feeling and the same idea as those who wrote it. Understanding technical and scientific information is difficult in your own language and it is even more difficult during the translation. For this reason our translators, before translating, must know the product and the subjects dealt in the texts.
Differently from other translation agencies that do not have internal staff and they use automatic translation software, in Redimec all languages are handled internally by specialized personnel; the translations are entrusted to personnel with specific experience in the requested sector, all at very competitive prices.
The translation division has a considerable experience in the translation of texts of the most varied types and an archive of tens of thousands of terms in different product sectors.
Send us the text to be translated per e-mail,
we forward to you a free quotation!
PHARMACEUTICAL VALIDATION
In the pharmaceutical and cosmetic industry, every production process must be validated with documented tests according to the standards of the GMP (Good Manufacturing Practice) and GAMP (Good Automated Manufactuing Practice) guidelines.
This check occurs by carrying out qualification protocols drawn up during the validation process.
Redimec is able to develop all the necessary documents to validate pharmaceutical or cosmetic production lines, machinery or equipment in close collaboration with its customers, relying on internal staff with a degree in Pharmaceutical Science.
The validation process consists of the following checking phases:
• Functional Specification (F.S.)
• Design Qualification (D.Q.)
• Installation Qualification (I.Q.)
• Operational Qualification (O.Q.)
• Performance Qualification (P.Q.)
• Maintenance Qualification (M.Q.)
• Standard Operating Procedure (S.O.P.)
• Computer System Validation (C.S.V.)
• Cleaning Validation
• Factory Acceptance Test (F.A.T.)
• Site Acceptance Test (S.A.T.)
• User Requirements Specifications (U.R.S.)
• Software Design Specifications (S.D.S.)
• Hardware Design Specifications (H.D.S.)
TECHNICAL REGULATIONS
The observance of EU directives and regulations as well as of the national laws and rules relating to machine safety is a fundamental condition for the commercialization of machines and equipment with the certainty that they comply with the requirements of the law.
Redimec, in close synergy with the customer, checks that all safety and health requirements are met and it drafts the necessary documentation so that the conformity of machines and equipment can be certified and approved.
The followings are among the most common directives that Redimec daily applies:
SURVEYS
A special team made up of engineers, experts and lawyers allows certifying and surveying products, machines and plants.
Redimec is therefore able to assist customers during all phases of approval and certification complying with regulations and laws for example in the context of Party-appointed Technical Consultant, offering a complete support in civil and criminal cases or in economic disputes.
CERTIFICATIONS
Partnerships with leading accredited laboratories allow Redimec customers to perform laboratory tests and certifications in the areas of EMC, PFE, EML, ISOBUS, MVR, RF, ENDURANCE, ATEX, PED standards.
DRAWINGS
We carry out two-dimensional and three-dimensional drawings whose surfaces can be coloured (rendering) for a photorealistic display of products.
Setting with trasparency and exploded views for spare parts catalogues.
It is also possible to make dynamic (animated) drawings and exploded views which can be used to show product assembly or machinery operation in a simple and clear way.
PRINTING
All documents can be printed both in colours or black and white through digital reprography laser technology, from format A6 up to format A0.
Tailor-made formats and binding solutions can be developed according to the customer's needs.
Our service ensures:
LABELLING
All adhesive labels and plates are conceived and carried out using machines that can print on materials such as PVC or vinyl.
Pictograms comply with the UNI EN ISO 7010:2012 standards and with the ANSI Z535 and ISO 3864 American standards.
The pictogram layout, dimensions and colours are strictly defined by such standards.
Production headquarters 1:
via Einstein, 16
20019 Settimo Milanese (MI)
tel. 0039 02 33503341
fax 0039 02 70036000
Production headquarters 2:
via Libertà, 35
20019 Settimo Milanese (MI)
tel. 0039 02 33503341
fax 0039 02 70036000
General Sales Conditions