Keeping your drug product development and CTM manufacturing under one roof. The DME team had to swiftly adjust design specs, including HVAC, piping, and lighting to accommodate the size of the new manufacturing Fast track pharmaceutical facilities.
So we can avoid bottlenecks and backups on the analytical end, and your project stays on track. DME had collaborated with the construction company previously, which turned out to be a huge asset.
The refurbishment itself was done over eight weeks in the summer ofas a cross-disciplinary and fast-track project mutually executed by NNE and LEO Pharma. View our comprehensive equipment list. Working within the compact ceiling cavity, the mechanical ductwork distribution, piping and associated terminal coils had to not only take into Fast track pharmaceutical facilities the new equipment, but also allow for maintenance access.
Also, equipment and piping was dismantled and renovated. In connection with the upgrade of the production processes, work was focused on powder handling, aseptic handling of inoculation tanks and health, safety and environment HSE.
Also, transport routes to and from the production were optimised and a better working environment was obtained. At Metrics Contract Services, we target a healthy balance of four analytical chemists to every formulator.
With the overall goal of ensuring compliance and security of supply, the objective was to bring the production area to a fully modernised level in terms of safety and working environment. Advanced pellet formulations for sustained, pulsed, modified and delayed release Tablets — including coated and matrix Powder and bead-filled capsules Oral liquids and suspensions Delivering full analytical support.
With that in mind, LEO Pharma had a great basis for assembling an effective project team and for having all resources in-house. Due to meticulous planning and coordination and involvement from all project areas, the shutdown lasted only 10 weeks, and LEO Pharma was able to re-start production earlier than expected.
Engineering Package, Construction Design A leader in advanced technology and cleanroom construction, this client needed help with a fast track project for a contract pharmaceutical manufacturing company. Metrics Contract Services offers formulation development services for a wide range of oral dosage forms: A new air-cooled chiller plant needed to be installed; new plumbing fixtures and piping were designed to connect new drains to the existing sanitary system; distribution piping for cold and hot water, compressed air, and tepid water systems were included; and electrical fixture designs were developed using new sealed clean room lighting and power distribution panels.
Midstream in the project, new client-supplied production equipment arrived, which turned out to be larger than originally anticipated.
A facility fit for the future The project entailed renovation of production areas and technical rooms as well as conversion of the existing office facilities into open and bright office spaces in a modern design.
Having a solid relationship built on trust, DME was able to smoothly interact with their client. SOPs can be used for all phases of the FDA submission process Fast-track development for clinical trial materials in four to six months Batch sizes of less than 1 kg up to kg Seamless scale-up to commercial manufacture Developing a wide range of oral dosage forms.
Taste masking for solid and liquid presentations Metrics Contract Services offers Fast track pharmaceutical facilities development services for a wide range of oral dosage forms: Review our comprehensive analytical testing services.
Of course, behind our successful formulators is a team of more than 90 analytical chemists. Thorough planning equals fast execution In order to ensure that the project was structured optimally from the beginning - and to generate a mutual overview of the project - the team created an object breakdown structure OBS forming the basis for the document production and later execution.
Advanced pellet formulations for sustained, pulsed, modified and delayed release Tablets — including coated and matrix Powder and bead-filled capsules. Offering full pharmaceutical drug product development services. DEA registered for Schedule II-V controlled substances and equipped with potent and toxic drug handling capabilities, Metrics Contract Services state-of-the-art facilities enable us to navigate the development pathway through Phase I-III all in the same building.
The project scope focused on the transformation of a shell space in an existing facility into new cleanroom manufacturing facility for a newly FDA-approved product.Facilities & Equipment Pharmaceutical Development Analytical Testing Clinical Trial Manufacturing Potent Products Metrics Contract Services offers formulation development services for a wide range of oral dosage forms: including analytical testing and seamless scale-up (including fast track.
Joint team delivers fast-track optimisation of API facility mail LEO Pharma is an independent, research-based pharmaceutical company and one of the world’s leading companies within the treatment of dermatological diseases.
Fast Track to Clinical Trials Capabilities In addition to our complete range of drug development capabilities, we offer the following services to expedite projects on a fast track for clinical trials.
A leader in advanced technology and cleanroom construction, this client needed help with a fast track project for a contract pharmaceutical manufacturing company.
The project scope focused on the transformation of a shell space in an existing facility into new cleanroom manufacturing facility for a newly FDA-approved product.
Technology & Services Fast-track Pharmaceutical Facilities a report by NNE Being the first to market has been the key to success in almost every manufacturing industry.
bioGO™ Modular Pharmaceutical Facilities Germfree manufactures complete modular facilities to provide flexible cGMP-compliant production space and R&D laboratories.
Our bioGO™ Fast-track Adaptive Modules incorporate aseptic process areas as well as containment for potent APIs.Download