Contract manufacturing

Contract manufacturing

Bioglan’s premises are comprehensively equipped with modern laboratories and production areas for semi-solid products such as gels, ointments, creams and liquids. The facility is equipped for large-scale manufacturing and produces for sale in Europe, Australia, Middle East, Far East and Africa.

The contract manufacturing process includes dispensing, bulk manufacturing, filling, quality control, and release.

• Facility and equipment designed for pharmaceutical production
• Validated purified water system with tap points in every production room
• Filtered air without re-circulation in all rooms were product and raw materials are exposed to the environment
• Separate area for dispensing of active material and flammable material
• Climate controlled and refrigerated warehouse space
• World-wide distribution support

Dispensing

A separate area for weighing raw materials is integrated with the warehouse. A dedicated area for weighing flammable materials and potent active substances is also available.

Bulk manufacturing

Bulk manufacturing is performed in six stand-alone units, ranging in capacity from 20 to 1250 kg. All product contact surfaces are made of high quality stainless steel or plastic. All equipment has integrated systems for heating and cooling. Most of the equipment also has pressurisation and homogenisation ability, and can be operated under vacuum and/or nitrogen atmosphere. Units also have sub vessels for emulsion manufacture. One of the units is able to handle flammables.

Filling

Filling can be performed on any one of three lines. There are two filling lines for plastic, laminate and aluminium tubes and one line for filling bottles and jars

Quality control

Quality is important to Bioglan. All manufacturing activities are regulated by the quality system and controlled by the Quality Assurance department. The quality system fulfils all the requirements of EU GMPs. The Quality Control laboratory ensures compliance to specifications, from raw material to the finished product. The laboratory is equipped with state of the art equipment appropriate for topical products.

Release

At Bioglan, products can be released for EU or other markets. If requested by our customers, Bioglan can perform: on-going stability studies, Product Quality Reviews, audit of API suppliers, product complaint summaries or other requirements demanded by the authorities.