Alpine Pharma groups

Process
Raw Material Medicament Preparation Gelatine Mass Preparation Encapsulation Process Capsule Pre-shaping, Washing and Semi Drying Capsule Drying Capsule Inspection Capsule Printing Quality Assurance Packing Storage Process Conditions
Raw Material Released from stores for manufacturing process - in accordance with the quality control, GMP standards and practices followed by the pharmaceutical industry with minor variations to suit internal control and quality assurance system.
Medicament (paste oil Fill Material) Preparation. Precise Weighments, Mixing, Homogenizing. De-aeration, sieving and preservation in accordance with the CGMP standards.The quality assured medicament/fill material is than released for the encapsulation process.
Gelatine Mass Preparation Precise Weighments, Mixing, heating, De-aeration, colourisation (if required) and quality testing. The quality assured Gelatine mass is than released for the encapsulation process. The entire process from mixing till testing is carried out in custom manufactured Gelatine Reactor.

Encapsulation (Capsule manufacturing) Process Gelatine mass and paste/oil Medicaments (fill material) are fed to the Encapsulation machine by feed system. Machine converts Gelatine Mass into ribbon, cuts and forms shapes and sizes of capsule shell. Medicaments - precisely and automatically weighed and injected into the Gelatine shell, formed and sealed, by automatic process controls. The entire in-line process is synchronized to a very fine degree to form a hermetically sealed capsules, by a precise process control system.

Product Change parts Die Roll sets/segment (wedge) are precisely custom manufactured on the state of the art CNC machines to exacting specifications of the clients w.r.t. size, shape and fill weight and application of the product.

Capsule Pre-shaping, Washing and Semi Drying Products are pre-shaped, washed with solvents for de-oiling purpose and semi dried in tumbler washer drier units.The solvent free/de-oiling Systems are also supplied where use of Solvent is not recommended or prohibited.
Capsule Drying Capsule Drying - Products are dried in precisely controlled Air-conditioned and De-humidified chambers, for moisture removal from Gelatine shell. Drying cycle depends on product characteristics and client's specific requirements of softness of the product.
Capsule Inspection Capsules are manually inspected for physical defects. For precise quality assurance for sizes and weights, Equipment such as sizing and sorting can be used. Capsule Printing Capsules are over-printed for logos or trade marks, if required.
Quality Assurance Quality assurance system is rigidly followed right from raw material, intermediate production and post production stages to ensure that all relevant GMP, pharmacopeial and company standards are fully met. Finished products are subjected to laboratory tests for physical, chemical and micro-biological characteristics, as required under USP/BSP/other international standards.
Packing Products are strip packed, blister packed, bottle pack and bulk packed as required.Bottle packing involves automatic counting, capping and sealing, labeling and cartooning. Storage Capsules are stored in a cool and dry place, before dispatch.

Process conditions Right from raw material stage till finished products are stored, controlled and precise air temperatures, humidity and air flow system are strictly maintained, as per our specifications.