CLOSE

News

10th World ADC in London

Now in its 10th year, World ADC London prides itself in being the industry-leading conference to help forward thinking researchers from the pharmaceutical, biotech and academic community advance the development of antibody-drug conjugates. Get together Read more…

CPHI JAPAN 2020 HAS BEEN POSTPONED

The event, which was supposed to take place from 16 to 18 March 2020, has been suspended. The decision to postpone the event was not taken lightly and was made in agreement with all interested parties. The organizers are currently Read more…

CPhI Worldwide Frankfurt 2019

We look forward to welcoming you at our trade fair booth during the 30th CPhI Worldwide in Frankfurt, Germany (5 - 7 November 2019). Please check our video invitation below and visit us at Read more…

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 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 Read more…

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.

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 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.
  • 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

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.

REPARTO COMMERCIALE
sales(at)microchem.it
REPARTO QUALITÀ
qa(at)microchem.it
REPARTO TECNICO
tech(at)microchem.it
LABORATORIO
lab(at)microchem.it

Microchem S.R.L., a sole shareholder company

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.
Subject to management and coordination
activities of AL.GA. Holding SA

T. +39 0523 981130
F. +39 0523 942935

contact(at)microchem.it
microchem(at)pec.it

English
Italiano English