Jamil Orfali GIANT labs GmbH

We are a company in the field of micro-particle analytics. Our unique selling point is the combination of services in the analytical laboratory and development projects for the approval or development of drugs as well as system production or adaptation.

We offer individual and personal support by competent experts, with the aim of delivering results as quickly as possible and creating analytical/development plans tailored to customer needs.

In the laboratory, we are able to determine unknown materials in samples using micro-particle analysis and determine the morphology of organic, inorganic and metallic substances. The mixture of optical microscope and laser spectroscopic analysis modules enable the investigation of particles down to the micrometre range. Organic and inorganic samples are analysed using FT-IR or RAMAN spectroscopy. The membranes required for this are manufactured in-house and also sold. We are thus able to track microparticles from visual inspection to isolation and determine the shape, number and identity of foreign bodies and product-related particles in the samples. Our staff carry out particle counts according to USP 788, membrane counts and sub-visual and visual analyses, among others. This combined with a comprehensive database enables us to find and identify every particle within 24 hours if required. We can also determine the silicone layer in syringes, cartridges etc. and establish a correlation to the silicone layer quality and possible influence on the formulation.

At GIANT labs, we see ourselves as both service providers and consultants. We help to evaluate new project requests, carry out highly critical troubleshooting, advise on upcoming analyses and support with their interpretation. We also help with requests from authorities, with routine quality control or necessary audits. At the end of the process, there is a scientific report including photo documentation, which is precisely tailored to the needs of our customers.

Another part of our entrepreneurial activity is the production of the systems needed for micro-particle analyses. If necessary, these systems can also be customised to meet the specific needs of the customer. The associated services are also part of our portfolio, such as regular maintenance, recalibration or any necessary repairs.

Our customers include well-known institutes and companies from the pharmaceutical, medical device and automotive industries, among others.

Our competence team is made of the most capable employees in their respective fields, who have more than 20 years of professional experience and who have jointly decided to be the personal analytics partner of our customers.

Here is an overview of our portfolio:

- Method development - Creation of individual analytic plans - Visual inspection/documentation - Particle isolation - Particle counting from 2 µm - Identification of organic, inorganic and metallic particles - Maintenance and repair of in-house and third-party systems - Carrying out IQ, OQ and PQ tests - Customised system configurations