Skybiotech Life Sciences Pvt. Ltd.

1.1 BRIEF INFORMATION OF THE FIRM:

The company, SKYBIOTECH Life Sciences Private Limited, is a professionally managed proprietary pharmaceutical manufacturing company having capacity to produce a wide range of Oral Solid Dosage Formulations i.e. Tablets, Capsules, Dry Powder Syrup and Oral Rehydration Salts.
 

The manufacturing facility is located at about 10 km away from Aurangabad on Gut No. 6, Gevrai Tanda, Pathan Road in a pollution free environment surrounded by farms and greeneries all around. There are reputed pharmaceutical companies in the nearby vicinity.
 

Presently, the company has tied up with companies like Ajanta Pharma Ltd., Wockhardt Ltd., Glenmark Pharmaceuticals Ltd., Generic Healthcare Pvt. Ltd., Galaxy Pharmaceuticals Mumbai, Galaxy Pharmaceuticals Kenya, Spirit Pharmaceutical and tied up with few merchant exporters from Mumbai, and supplying finished goods to African Continent and CIS countries.
 

The company has a mission to continuously supply products of highest quality standards conforming to both domestic and international regulatory standards. To achieve this noble mission, the company is having international standard manufacturing facilities, integrated quality systems, highly qualified, trained, competent and committed personnel. The company has already a wide distribution network around the world to supply the required quantities to the esteemed customers.
 

Additionally, the company is committed to continuously improve its facilities and quality systems to comply with current Good Manufacturing Practices and Regulatory Authorities as well as customer’s requirements.
 

1.2 LICENSED MANUFACTURING ACTIVITIES AT THE SITE:

The pharmaceutical manufacturing facilities of SKYBIOTECH Life Sciences Private Limited is having manufacturing license numbers ADSL, ADDA issued on 06/08/2024 and valid up to 05/08/2029 by the State FDA for manufacturing of Tablet, Capsule, Powder in the form no. 25 respectively

 

KEY FEATURES OF THE MANUFACTURING PLANT

Water system: To provide purified water in manufacturing we have a RO + EDI of 100 Ltr per hour capacity with online display of all the parameters of water which are maintained for USP – 44 water.
 

There is a loop system for the distribution of the pure water in manufacturing area and 7 outlets to draw water from these loops so that water is under continuous circulation and distribution of water loop are long enough, which lead to flow that never stop.

The water system is designed and installed by Chemicon Pvt. Ltd., Pune on “turn key” basis. The supplier is reputed and has done such kind of projects for many multinational pharma companies in India and has excellent track record of supplying good quality systems and equipments.
 

There are 45 nos. of Air Handling Units for cool air 2 AHU of 10 installed on a fully covered service floor, the design and the execution of these Air Handling Units systems was done by VOLTAS Ltd. on a “Turn Key” Basis. The system is attached to TWO reciprocating type water Chillers of 60 TR each. The idea of providing TWO chillers is that one chiller can act as a backup if one chiller goes under maintenance and also both the chillers can be run simultaneously to achieve temperature even very highs by more than 4°C.

All the passages and lobbies are 2 meter wide and all the passages are covered under clean air according to Class D: (100000).

All packing halls are separated with each packing line, presently we have 8 such cubicles (three each for tablet lines, three for capsule lines). Every cubicle has been covered with packing line. All packing halls have separate AHU’s and fall under Class D: (100000) area.

Separate change rooms and entry at the entry point for personnel such as:

1 Labour – Male 2 Labour – Female 3 Staff 4 Management and Visitors.
All these change rooms are provided with Air Shower (as a filter of 0.5 micron). Hence, all the change rooms are not only air conditioned but also self ventilated.

Two Air Showers are installed at the entry point after the change rooms and before the entry into the manufacturing area, to ensure no dust particles reach the aseptic areas.

We covered the Store rooms & Ware house separate AHU which complies to class D (100000) areas and dispensing and sampling rooms under separate AHU which complies to class C (10000) area. A separate Reverse Laminar air flow and Dynamic pass box is provided for each dispensing and sampling room which maintain Class A (100) air cleanliness class.