NEWS HISTORY PROJECT MANAGEMENT ACTIVITIES FEATURES CERTIFICATIONS SAFETY CONTACTS ITA ENG Our site stores cookies on your computer. These cookies are used to offer more personalised services and improve each day. Continuing to browse our site implies acceptance of our cookie policy. See our legal notes or Close Microchem provides contract micronization of active ingredients and excipients for the pharmaceutical industry Our contract micronization services have been refined and improved based on actual in-depth experience gained from our daily processing operations. Our state-of-the art material handling service applies micronization technology based on this combination of improved equipment and practiced, processing skill. Microchem operates under a comprehensive Quality System to comply with all regulatory authorities and harmonized requirements. Microchem is GMP compliance and ISO Certified. Download our brochure News MIcrochem accredited by MHLW Japan On 19/01/17 Microchem has received the renewal of the accreditation certificate as foreign drug manufacturer by the Minister of Health, Labour and Welfare (MHLW) Microchem inspected by Italian Veterinary Agency On 04/10/16 Microchem has been inspected by the Italian Department of Veterinary Public Health (DGSAF) for the verification of compliance with Good Manufacturing Practices. A GMP certificate has been issued and it has been published on the website EudraGMP. Microchem inspected by IT AIFA Microchem, on 13-14-15 May 2015, has been inspected by IT AIFA for a GMP inspection. The compliance of our processes to the current GMP has been confirmed. New investments February 2015 - Microchem grows and recently was launched a further investment plan. A new area used for washing equipments was made, designed to ensure a more rigid segregation of the washing cycle even for the dedicated parts. The most recent and stringent pharmaceutical standards have been widely respected for materials and finishes. Microchem inspected by US FDA Microchem is pleased to provide an update on the most recent US regulatory status of its contract micronization facility. On 31 March 2014, an experienced investigator from the US FDA started to conduct a 3-days GMP inspection in Microchem. The inspection has been successfully concluded. No Form 483 was issued. Revamping of the clean rooms October 2012 - Microchem, in a perspective of continuous quality improvement, has recently carried out a revamping of the clean rooms upgrading them to the last pharmaceutical standards. History It is a story that started a long time ago, around the mid-sixties, when the micronization of active ingredients in pharmaceuticals was more or less unheard of. In those days, fluid jet micronization was being used, in practice, more often in other sectors, for example in mineral, herbicide and antiparasitic products. By following this principle and adapting it over the course of time to the increasing demands of the chemical and pharmaceutical industry, micronization started to take its first steps. At first, the orders came from small and medium-sized companies that found it difficult to set up key departments soley for their micronization requirements, but then, in time, the first “blue chips” joined in. With the consolidation of Microchem in 1978, and also at the Italian level, micronisation became fundamental. At that time Italy was the number one world market for the production of APIs and even today, it remains in third place, headed only by India and China. Instilled in the company is the DNA of complementary skills held by its founder engineer, Alberto Martinoli: the art of designing and specifying micronization equipment and machinery and, on the other hand, the art of simply raising service levels to an absolute maximum. It is quality and service that are the focal points at Microchem: quality assurance, quality controls and careful laboratory analysis constitute the three pillars on which Microchem bases all of its micronization activities. By service we mean the capacity to adapt the micronization specifications to the needs of the client, the constant presence of our staff and the flexible and dynamic approach that typifies the company culture at Microchem. Project Management This scheme shows how Microchem works with its potential and existing clients. The relational aspect is really important for the company and all its employees. For us, quality means loyalty: it gives us enormous satisfaction to see how our clientele has remained loyal to us over the years, giving rise to long-lasting relationships and enabling us to create and build new profitability. Activities Scalability Our spiral jet mills have been designed to guarantee precise scalability. This enables the active ingredient to be followed from its first R&D phases through to marketing; it allows us to operate with the same product from batches of 0.2 g up to several tonnes. Extremely precise PSD Thanks to our technology we are able to obtain very fine and precise particle size distribution with only a single micronization passage for nearly all pharmaceutical ingredients. MICRONIZATION Microchem provides contract micronization of active ingredients for the pharmaceutical industry. Micronization is undertaken using a range of fluid jet mills, conceived and designed by us. Excellent Yield We guarantee to reduce the product build-up and to achieve yields higher than 99% for the industrial process, starting from quantities of 1kg No heat generation Thanks to the isothermal feature of our jet mills, we can micronize any pharma ingredients, even those with a very low melting point (30-40°C). DELUMPING Spiral jet mills and a hammer mills can be used successfully not only to reduce the particle size, but also to remove lumps and agglomerates. DISPENSING Our clean rooms and isolators can be used to dispense and re-pack bulk API into small containers at any amount. QUALITY CONTROL LABORATORY ACTIVITIES Identification analysis Cleaning validation study Particle size distribution analysis Microbiological monitoring of environment, water and equipment surface Contract laboratory for PSD analysis QUALITY CONTROL INSTRUMENTS Malvern Mastersizer particle sizer FT-IR Melting point analyser UV-Vis spectrophotometer Optical microscope with image analysis Laminar flow hood for microbiological monitoring VALIDATION ACTIVITIES Process parameter study, to define and support the validation activity Process Validation Analytical method Validation Features Demonstrated compliance with current Good Manufacturing Practices (cGMP). Proven expertise in process development for Fluid Jet Mill particle reduction. Facility and equipment design to prevent cross-contamination. Independent clean rooms for controlled environments. Completely independent air-handling systems with dedicated HEPA air-filtration for each clean room. Clean rooms and equipments engineered for complete cleaning, rapid assembly and increased productivity. Equipment designed to conserve product and give high yields (low process loss). Milling equipment and contract service available from R&D or laboratory scale up to large volume commercial production. Qualified and filtered compressed process fluids. Steroidal compounds handled in dedicated process clean room and equipment. Inert gas micronization for explosive or oxygen sensitive compounds. Full Quality Assurance and Control. Rigorous particle size measurement using laser analyzers. Complete traceability of all materials. Qualified technicians and highly trained personnel perform process operations and provide technical support. CERTIFICATIONS Microchem maintains and continuously seeks to improve its Integrated Quality, Safety and Environment Management System for the micronization services. Microchem is in compliance with the current Italian regulations, which meet the requirements of good practice and quality controls recommended by ICH Q7, as well as the applicable laws on Health, Safety and Envionment. Internal and external cGMP and ISO audits are constantly performed to ensure the continuous compliance to all applicable requirements. US FDA ISO 9001 ISO 14001 PMDA Korean FDA IT AIFA DOWNLOAD Particle size distribution example IQNet - ISO Certificate SQS - ISO Certificate Brochure Safety & Containment Clean Room ISO 8 (class 100.000) periodically qualified, designed to offer the best environment for the handling pharmaceutical products, avoiding environmental contamination and preventing product cross-contamination. Differential pressure cascade to obtain barrier effect and powder containment. Safety Microchem sustains an active management system in which it has integrated an occupational health and safety management, as to OHSAS 18001 standard. Contacts Microchem S.R.L. Via Turati 2 I - 29017 Fiorenzuola d’Arda (PC) GPS - 44.91855, 9.936372 P.Iva - CF - Reg. Imp 01026710333 R.E.A. PC 122206 Cap. Soc. € 93.600 i.v. T. +39 0523 981130 F. +39 0523 942935 contact(at)microchem.it microchem(at)pec.it COMMERCIAL DEPARTMENT sales(at)microchem.it QUALITY DEPARTMENT qa(at)microchem.it TECHNICAL DEPARTMENT tech(at)microchem.it LABORATORY lab(at)microchem.it Powered by SP