ROVI - Aseptic Filling of Small Volume Parenterals

Laboratorios Farmacéuticos Rovi (by its Manufacturing Division), began contract manufacturing in 1995.We have more than 60 years' experience in the aseptic filling process of Small Volume Parenterals (SVP), which includes using pre-filled syringes and vials under sterile conditions. At the end of 2005, the Manufacturing Division of Rovi has been separated into a new and independent company dedicated to contract manufacturing. Its name is RoviCM.

RoviCM is a first-class independent contract manufacturing company offering global solutions to today's pharmaceutical and biotechnology manufacturing requirements. Quality, time, price and flexibility are the main keys to our philosophy.

ASEPTIC FILLING OF SVP SOLUTIONS

RoviCM specialises in aseptic filling and packaging of small-volume parenterals in prefilled syringes and vials, with a total annual capacity of 150 million pre-filled syringes and 12 million vials.

In 2005, RoviCM manufactured 91 million PFS and eight million vials for more than 25 countries.

Since 1994, RoviCM has been the top manufacturer and supplier of SVP using pre-filled syringes in Spain, and the second most important at international level since 1996. Actually, with more than 8,000m² of facilities, it has become one of the most highly-flexible European plants.

The key to our products' quality, efficacy and safety is the creation of documentation that is simple and clear, the close follow-up of our quality system and the use of advanced technology.

PRE–FILLED SYRINGES AND VIALS

RoviCM manufactures pre-filled syringes from 0.2ml to 5ml and vials between 2ml and 20ml under sterile conditions into different clean areas classified with grades A, B, C and D. The whole process is carried out in an aseptic filling process, which has been validated, at least, with media fill once every six months.

RoviCM maintains a very high standard of quality and exigency that is reflected in details such as the use of specific filling tools dedicated to each product. Strict inspection systems guarantee the suitability of the finished product and we employ fully automatic inspection machines, 100% labelling evaluation, and blister verification to detect syringes without plunger rods, labels or needles.

INTEGRATED SYSTEM MANAGEMENT, OPTICAL VISUAL SYSTEM AND WATER FOR INJECTION SYSTEM

ROVI's quality commitment has led to important investments in new technology, such as the integrated system management SAP R3. Production lines are controlled by an optical system which assures the quality of the product in each phase. The plant has exhaustive control of parameters in all clean areas, manufacturing the highest quality of purified water for injection. Furthermore, different air pressure and particles are monitored 24hrs a day to assure the correct grade classification in each area. All our systems are under the control of approved validation and calibration plans.

QUALITY CERTIFICATIONS

RoviCM owns the GMP certificate, UNE-EN ISO 9.001:2000, ISO 13.485:2004 and has been approved by the MCA for various products and clients.

RoviCM has the goal of attaining FDA certification during 2006.

PACKAGING

We label and package pre-filled syringes and vials using clear acetate label stock, with or without graduation marks and offer syringe and vial packaging in blister trays or printed cartons.

We also label syringes and vials ranging in multiple languages and in a variety of label stocks. We package them to fit individual requirements, such as single-printed cartons or multiple and bulk packs.

CLINICAL TRIALS

Working to both USA and European standards, we offer expert, cost-effective, flexible and reliable support for your clinical supplies needs. We can:

• Manage the entire process from manufacturing
• Provide temperature-controlled storage facilities
• Offer versatile labelling options
• Blind-study materials and comparators
• Handle controlled drugs

DEVELOPMENT

RoviCM advises companies on the strategy for introducing a new product, from pre-clinical technical development to a multi-national commercial launch. This involves project management, due diligence, production strategy, launch strategy, technology transfer and regulatory issues. This ensures that a new product is launched which meets all of the regulatory requirements and it is marketed properly.