DOC was present last week at the PDA Annex I Conference in Dublin, where the main topic addressed was the revision of the EU GMP guideline.
As an invited speaker, Mario Sala Tenna, SME in Validation of Critical Utility Systems, Process Manufacturing Equipment, Computer systems and data Integrity, spoke about the impact of the revised Annex 1 on Pharmaceutical Water & Steam Systems.
View some of the event’s highlights and speakers interviews below!
Stilmas Expands its North American Operations with the Acquisition of Mar Cor Purification’s High Purity Water Business Based in Burlington Ontario, Canada
Milan, Italy November 1, 2018/PRNewswire/ — Stilmas is pleased to announce that effective November 1, 2018 it has acquired the assets of Mar Cor Purification’s High Purity Water Business based in Burlington, Ontario, Canada. The new company will be named Stilmas Americas, and will serve the North American market, expanding the Mar Cor Purification High Purity water portfolio of products. Mar Cor Purification currently manufactures a line of water purification equipment platforms that are compliant with the current USP and EU Purified Water (PW) and Water for Injection (WFI) standards. They specialize in standard and custom engineered turn-key systems for the Pharmaceutical, Biotech, Cosmetic and Semi-Conductor markets.
The Masco Group, with its Companies Stilmas, Olsa and DOC, is a global market leader in the field of pure water technologies and systems for the pharmaceutical and cosmetic industry. The Masco Group is headquartered in Milan, Italy, with operations in France, China, Russia and USA. Stilmas manufactures state of the art Pharmaceutical Quality Water Systems that include Multiple Effect Stills, Vapor Compression Stills and Pure Steam Generators along with other standard products.
Alberto Borella – CEO Masco Group: “We have found in the High Purity Business Line of Mar Cor Purification the perfect complement of products and competencies to successfully carry out our vision and grow our business. Stilmas Americas will become the reference clean media provider in North America.”
Benjamin Roczniak – President Stilmas Americas: “We are excited that we now have a complete portfolio of State of the Art Biopharma water products that will allow us to provide our customers with complex turnkey solutions.”
Stilmas Americas will be the hub for selling, engineering, manufacturing and servicing Stilmas equipment in North America, becoming a unique player to offer a complete range of pure media technologies in the North American market.
For further information, visit Stilmas website at www.stilmas.com.
DOC experts are invited as speakers in the workshop organized by PDA Italy Chapter in Milan on April, 20th.
Topic of the day are the latest requirements on qualification of materials used in the manufacturing process and as component of primary packaging.
Our speech will be focused on “Extractables and Leachables qualification of the in process materials and primary packaging: regulatory overview and design of the study”
Follow the link below for detailed information and take the occasion to meet our experts!
DOC will Sponsor the seminar organized by ELCHEMA Paliginis Bros in Athens, Greece on November 21, 2017.
Topic of the day will be “Glass, Elastomers, Plastics, Polymeric Material in Process Devices for Pharmaceutical Systems: Qualification Approach based on recent USP & EU regulation”
Antonio Legnani, Technical & Validation director, and Federica Annovazzi, Project Manager, will share DOC experience in all aspects related to Material Qualification and Sterilizing Grade Filter Validation as ruled by the recently revised USP monograph and European regulation.
Focus will also be on the Qualification studies of in-process material (e.g. filters, tubing,..) as well as primary containers with the specific product formulation as it is becoming an increasing “hot topic” in EU as well in USA GMP Community.
Download the Seminar Program for additional information and subscription
Save the date. DOC will actively sponsor the upcoming PDA Italy Chapter event in Bari on 05-06th of October 2017: “Manufacturing trend of parenterals: a glance to the future”.
We are looking forward to seeing and meeting you at our tabletop!
Masco-Group has retained Industrial Investment Company of
RAG-Foundation as long-term majority shareholder
The Masco Group with its business units Stilmas, Olsa and DOC is a global market leader in the field of pure water technologies and systems for the pharmaceutical and cosmetic industry.
Masco Group has a unique track record and experience of more than 100 years in Pure Water Systems as well as complete solutions for liquid production pharmaceutical plants, including product preparation areas. Moreover, the group offers a wide range of services related to the validation in the pharmaceutical and cosmetic industry. The company has the honor to be a reliable and innovative business partner for the leading global and local pharmaceutical and cosmetic companies.
Taking into account the excellent growth opportunities regarding regional expansion, automation solutions as well as larger turnkey projects including balance of plant systems the ownership family has decided to team up with an experienced business partner enabling Masco not only to keep the traditional values of the company and their independence but also to combine it with the highly interesting knowledge and competencies of a global industrial network.
“We are excited to announce this strategic collaboration with RAG Investment Company which will support the acceleration of our business on the global scale. Our new strategic investor will allow Masco to maintain the entrepreneurial spirit and ensure that our business model, network of customers, partnerships and objectives are even reinforced to achieve new ambitious targets,” said Alberto Borella, CEO Masco Group.
Jürgen Wild the Managing Partner of RAG Investment Company:
“Masco Group is a flagship of northern Italy’s high tech industry which started very early in time to become a global player serving customers around the world. Their innovation spirit was always looking for best-in-class solutions satisfying the highest standards of its superb customer base. In addition, the company also developed forward its offering to customers from products to turnkey solutions. With the unique combination of in-house development, production, validation and service Masco Group is the recognized market leader. We are privileged to become the business partner of choice and will commit ourselves to the future success of this outstanding company.”
The Borella family maintains committed to Masco as shareholder and as board members in the management of the group.
Dr.Eng. Alberto BORELLA
CEO Masco Group
More than 1000 participants, more than 100 booths and many news. AFI 57° Symposium is about to start, confirming the success of the former editions. 12 Scientific Sessions and a Plenary Session open to everybody. And furthermore… “The start up piazza”, the workshops, the corners dedicated to category associations and the poster sessions.
See you in Rimini on June 7th-8th-9th, 2017
Visit us @ booth #78
Mr. Antonio Legnani, DOC Technical Director, will deliver the following speech during the upcoming three days Proceasep 2017 Annual Conference in Cuba:
“Calificación de Extractables y Lixiviables en los materiales en proceso y las formas terminadas: Parte 1: Aspectos regulatorios. Parte 2: Caso de estudio” / “Extractables & Leachables Qualification of In-Process Materials and Finished Forms. Part 1: Regulatory Overview. Part 2: Case Study”
About Proceasep Annual Conference:
PROCEASEP se ha convertido en uno de los eventos más importantes para los especialistas y técnicos que en Cuba trabajan en la industria biofarmacéutica. Este taller es una oportunidad única de discutir con expertos de clase mundial las últimas tendencias en la producción y las regulaciones relacionadas a esta industria y una vía para saber como implementar los últimos requisitos de las BPF en nuestros procesos productivos.
For additional detail discover more on: http://www.biocen.cu/prosep/pro.html
Mr. Antono Legnani, DOC Technical Director, will deliver two speeches during the upcoming two days APIC Annual Conference:
Day 0ne – Guide to Inspection and Process review for Sterilization by Filtration, over all regulatory requirements
Day Two – Glass, Elastomers, Plastics and Polymeric Material in Pharmaceutical System: qualification approach based on recent USP regulation
About APIC Annual Conference:
The Arab Pharmaceutical Industry congress (APIC) was designed to provide an innovative and comprehensive overview of the latest research developments in pharmaceutical machinery. Our events offer a platform for professionals to share knowledge, network and discuss trend in the pharmaceutical industry. Register now to join us in a day of knowledge sharing, networking and to get a chance to meet and get to know the services of pioneers in the filed.
For additional detail please download the official brochure below