Gmp - Import export

Do you want to manufacture and package cosmetic products yourself? You need to ensure that you comply with the ISO 22716 standard. Support in the implementation of GMP including : - Staff training - Drafting the different procedures according to standard ISO 22716 Quality control of raw materials and finished products Auditing of subcontractors and production sites Implementation of cosmetovigilance Translated with www.DeepL.com/Translator (free version)

We manage investment projects for you, such as production expansions, installation of new plants, greenfield construction projects, brownfield construction projects. We focus on the rapid implementation of your project. With these short project durations, you have low project costs and a high return on investment. We adapt our project management to the very specific circumstances of our clients Contact us for an initial discussion! This makes our project management flexible enough to handle the changes that occur in every project. Our focus is on short "time to market" and thus low project costs. This is the only way for projects to pay off quickly. We execute projects very quickly and achieve significant time savings compared to traditional project management. Pharmaceutical production •After qualification and commissioning, we also take care of the start of production. •Optimisation of the production parameters •Validation •Transfer to routine operation

Our production is done in specifically equipped rooms, to rule out the possibility of product contamination from the outside. This includes, for example: special access authorisation, airtight walls and ceilings, windows that cannot be opened, air supply to the rooms being filtered, higher inside air pressure in relation to the outside air, insect lamps to prevent contamination with insects, mandatory protective clothing, shoe covers, gloves and hair covers, written authorisation with documentation for all work or events taking place in the rooms, such as cleaning, conversions, malfunctions. We have specialised in the particular needs of the pharmaceutical, food and health industries. All production takes place under clean room conditions and in compliance with the highest hygiene standards. Some sections are FDA-approved. Food additives are processed in accordance with the HACCP principles and in compliance with the European food hygiene directives and are prepared for dispatch.

Technologies film-Extrusion (Mono and Coex) converting manual converting of special products packaging ("bag-in-bag") GMP Principles cleanroomproduction (ISO 14644-1, class 8 and 9) Pestcontrol / HACCP- Prinziples Traceability / Validation EU-Pharmacopoe / FDA / EU 10/2011 Kontaminationsfreie Verpackung („Bag-in-Bag“), declartion of conformität ISO 9001:2008, EC-qualitycontrol, In-Process-controlm certificates continuous improvment / quality audits / training

DESCRIPTION High stability on high capacity. Can handle multiple bottles size, types and shapes Type of metal used S.S 316 / 304 Certifications ISO 90012015, OHSAS 180012007, ISO 500012011, ISO 450012018 SPECIFICATION 6 Diving Nozzles One feeding table HMI and SCADA system with touch screen integrated user friendly and simplified software. Available certification up on your request UL, CE, GMP, FDA, ASME. Available documents up on your request I.Q (Installation qualification), O.Q Operational qualification), P.Q Performance qualification. Linear filling system. Star containing, sterilizer, capping and closing system One side labeling machine.

The GMP-compliant, compact Belimed Life Science Pharma cleaning system was specially developed for the preparation, cleaning and drying of components in contact with the product for the production of drugs or experiments in laboratories. The washer characterized by an uncompromising hygienic design, simple operation and low-maintenance construction. The design of the pharmaceutical cleaning system and the cleaning processes have been optimized for the highest demands based on many years of experience.

The PST sterilizer is completely designed and constructed according to customer requirements. The sterilizer is based on 15 standard cubic chamber sizes ranging from the compact masses 6-6-6 (H X W X D in dm) to 18-10-15 (H X W X D in dm) which can be individually adapted to the sterilization task. The saturated steam processes are optimized for solids as well as liquids in open containers and are based on many years of experience in the development and optimization of sterilizers for highest demands. In addition, steam-air-mixture processes for sterilization of liquids in closed containers are also possible.

The Belimed Life Science Saturated Steam Sterilizer (Process 6050) is suitable for a wide range of applications in the pharmaceutical and biotechnological industry and in laboratories. The saturated steam processes are optimized for solids and liquids in open containers and are based on many years of experience in the development and optimization of sterilizers that meet the highest standards. The sterilizer is typically used for the sterilization of production items such as bottles, tubes, pipe connections, metal containers, containers, cages, textiles and clothing. Optionally, the sterilizer can be extended with the process double jacket cooling with supporting pressure during cooling (process 6050 / 6065).

Designed as a cleaning system for containers, drums, pallets and other large-sized vessels, the PH 880.2 is part of an extensive model range (PH 820.2, PH 840.2 and PH 860.2). The tailored operational sequences for professional pharmaceutical processes maximises efficient throughput. Based on standardised technical design and years of Belimed Life Science’s experience in automatic cleaning, the PH washer range covers a wide range of cleaning requirements and features harmonised construction characteristics throughout the various models. The PH 880.2 combines highest possible component standardisation with the necessary design flexibility to achieve best possible adaptation of the machine to the requirements of the production process.

Extensive practical experience and close cooperation with customers and planners show us that less and less space is available for cleaning. In response to this fact we have designed the WD 390 PH with space-saving, shorter cleaning and drying cabins and shorter machine infeed and discharge distances. The WD 390 PH with its cleaning and drying cabins enables short washing cycles and at the same time a higher throughput of washed goods. The Modular Concept The WD 390 PH is equipped with five compact cabins that perform various functions such as cleaning, rinsing and drying in short wash cycles, enabling efficient cleaning and high throughput. In addition, the WD 390 PH offers access for maintenance and service from only one long side, as all units are arranged for easy servicing.

Industrial gears under very high loads and repeated shocks. Adapted to severe conditions: cement plants, iron and steel industry, mines, crushing…

With the Solotransa you’re in the right place for solutions for the transportation of GMP+ products. The fact that providing a quality service is always a top priority for us is underscored by the fact that we are GMP+ certified. By this means, we can guarantee that the transport complies fully with all relevant statutory regulations and legal requirements. For this special transport, we make use of tipping silo semi-trailers of 38 m3 to 66 m3.

30+ years of experience in stem cell technology Certificates of Analysis (to certify the quality and purity of stem cells ) Individual stem cells dosage Own stem cell laboratory and cryobank GLP/GMP registered facility ____________________