Alpa laboratories has dedicated manufacturing areas for different dosage forms. The production areas are designed to maximize output quality and quantity with minimal down time. One such feature is the availability of a service floor above each sterile manufacturing area for providing the best manufacturing conditions and enabling the ability to maintain the utilities without disturbing the sterile areas below. |
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The manufacturing areas at Alpa Laboratories are broadly divided into sterile and semi-sterile areas. Both of these areas are supplied with forced air ventilation supplied by independent supply systems for individual department. All sterile areas are centrally air-conditioned and supplied by independent utility supply systems for individual department. |
The critical work areas within the semi-sterile areas are also centrally air-conditioned. The independent supply systems are fed with separated air handling units to avoid cross air contamination. Pressure gradients are maintained and monitored and the required air quality of class 100, 1000, 10,000 and class 100,000 is maintained. |
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The combination of man, material and the systems enables Alpa Laboratories to produce a range of very high quality products. The well laid out and validated manufacturing process spanning all phases from raw material handling to finished goods storage is strictly followed for all product forms. Every step is documented in detail and historical data maintained for future reference. |
The salient features of our manufacturing facilities are…
• Well - separated and dedicated manufacturing areas for Beta Lactum and Non Beta Lactum products.
• Streamlined layout of machines and departments
• Separate air handling units for different departments
• Well-equipped maintenance department for routine & preventive maintenance
INJECTABLES
For liquid injections, the process involves producing the paranteral in a sterile area and feeding it to the automatic machines for vial filling, rubber bunging and cap sealing. Similar processes are in place for dry powder injections. The vials and ampoules are first washed in washing machines equipped with laminar airflow. Similarly ampoules are washed in washing machines also equipped with laminar air flow. The vials and ampoules are sterilized with the help of fully computerised and automatic dry heat sterilisers. Rubber closer equipment and rubber bungs in Decran bags are autoclaved in double door autoclaves. Alpa Laboratories has an installed capacity to produce over 5 million Vials and 1.5 million Ampoules per month.
TABLETS
The tablet manufacturing process involves the use of rapid mixer-granulators and fluid bed dryers to produce the material for compression in various shapes which is carried out at various multi station single and double rotary tablet compression machines. There are coating machines for film coating on tablets and then the tablets are packed in blister packs or strips as required. Alpa Laboratories can currently produce upto 90 million tablets every month.
CAPSULES
Equipment used for the production of hard-gelatin capsules are automatic filling machines, pam feeder, sorter, inspection machine and polishing machine. The filled capsules are packed in high speed automatic strip and blister packingmachines suitable for various sizes. The company has the ability to produce a whole range of formulations in both the powder and granulated forms. The installed capacity is over 30 million capsules per month.
CREAMS, GELS, OINTMENTS
The empty collapsible tubes are cleaned and sterilized prior to filling. The ready preparation formulated on various mixers and mills in controlled and sterile environment is fed to the filling machines. The semi-automatic machines perform the entire process of filling, sealing & crimping of the tubes in various tube sizes of Creams, Gels, Ointments, Sterile Ophthalmic Ointments and Sterile intra-mammary infusions. The installed capacity at Alpa Laboratories is 2 million tubes per month.