Tahira unwraps small volume parenterals manufacturing facility

Suraj Kumar Shah

In 2000 when APShah, Director of Tahira Industries along with V S Dhakaras, a stalwart in the pharmaceutical industry, started designing and creating a Small Volume Parenterals manufacturing facility in Mumbai. Shah gained proficiency in the field of pharmaceuticals and advanced to transform his dream into reality, now introducing a world class manufacturing facility of Small Volume Parenterals in Mumbai.

Located in Jogeshwari near the Western Express Highway & Jogeshwari Station, Tahira as a team believes adherence to strict international regulatory standards has become a prominent requisite to manufacture quality products of the highest level.

Manufacturing Facility

The production facility consists of two class `A’ filling zones, one for liquid ampoules or vials and one for dry powder vials, each having its own independent HVAC system, undertaking the filling and sealing of sterile ampoules and vials aseptically. The capacities are detailed here below:

Liquid Injectables

Vials: 2 ml - 30 ml - 9 million units per annum.

Ampoules: 2 ml to 10 ml - 12 million units per annum.

Sterile Powder Injectables.

Vials: 9 million units per annum. (Considering capacity involving larger doses).

Washing and Dry Heat Sterilization Zone

The Washing and Sterilisation zone is maintained under Class 100000. It also incorporates an independent HVAC system, to give added prevention of cross-contamination.

This zone consists of machinery listed below:

• Jet Ampoules washing machine under Class 100 Laminar Airflow Workstation
• Linear double track Vial washing machine under Class 100 Laminar Airflow Workstation
• Two double-door PLC based Dry Heat Sterilisers having an entry of material from this zone and downloading sterilised material in the cool zones with Class A Condition
• Steriliser I dedicated to liquid filling zone
• Sterilizer II dedicated to Powder filling zone

Moist Heat Sterilisation (Autoclaving) and Bung Washing Zone

This zone consists of the following machinery:

• Two double-door PLC based Autoclaves having an entry of material after passage under Class 100 Laminar Airflow Workstations and having arrangement of downloading sterilized materials in the Cool Zone under Laminar Airflow Workstations with Class A Condition.
• Autoclave I dedicated to liquid filling zone
• Autoclave II dedicated to Powder filling zone.
• This zone also incorporates an independent HVAC system to give added prevention of cross contamination
• One Bung wasing machine

Liquid Filling Zone (Sterile)

Liquid Filling Area having under mentioned facilities.

• Automatic vial filling, stoppering and sealing line under a Class 100 Laminar Airflow Workstation.
• Automatic Ampoule Filling Machine under a Class 100 Laminar Airflow Workstation.
• Separate Filtration Room.
• The Filling Room has a set of utility junctions for the required utilities (compressed air, nitrogen, oxygen, LPG, etc).
• Three Class 10000 / change rooms equipped with UV Lamps, hand drier, with a wash basin in the first CR.
• Cool Zone, for sterilized materials downloaded from the autoclave and DHS
• The Liquid Filling Area has been validated and certified as Class A

Powder Filling Zone (Sterile)

Powder Vial Filling Area having under mentioned facilities.

• Automatic powder vial filling followed by automatic rubber stoppering and automatic sealing line under class 100 Laminar Airflow Workstation.
• Separate Blending/ Class 10,000 Room.
• Three Class 10000 change rooms equipped with UV Lamps, hand drier, with a wash basin in first change room
• The Filling Room has a set of utility junctions for the required utilities (compressed air, nitrogen, oxygen, vacuum)
• Cool Zone, for sterilized materials downloaded from the autoclave and DHS

Utilities and Services

In a facility of this sort, there is a need of certain utilities such as compressed air, distilled water, water for injections, gases such as nitrogen, oxygen and LPG, we have provided for such requirements in the most efficient manner enabling us to undertake our production activities proficiently. Our entire piping layout has been done in S.S. 316.

Listed below are the utilities provided: Water Treatment (DM Water Plant)

• Distribution system attached to this plant consists of S.S. D.M. water storage tank, electropolished seamless S.S. 316 distribution piping with U loops and valves at user points and suitable filters installed promptly.
• Distilled Water Still (Multi column 300 LPH)
• Distribution system attached to this plant consists of S.S. Distilled water storage tank, electropolished seamless S.S. 316 distribution piping with U loops and valves at user points and suitable filters installed promptly.
• Pure Steam Generator with S.S. distributing line
• Air Compressor with S.S distribution line
• Vacuum Pump with S.S. distribution line
• Various Gases with S.S. distribution lines
• Effluent treatment Plant
• HVAC systems, each Area is provided the single separate AHU system

HVAC System

The HVAC system has been designed specifically to meet the requirements of the current G.M.P regulation, each having the capacity to maintain the required air flow and air quality. Terminal HEPA Filters have been installed in all critical areas, including the Washing and Sterilization areas. Facility for Visual Inspection and labelling or packing of finished ampoules and vials consists of -

• Visual Inspection units with black and white backgrounds and Tubelights.
• One ampoule labelling M/c. with packaging line on a conveyor belt.
• One vial labelling M/c. with packing line on a conveyor belt.

Quality Control Laboratory / Quality Assurance

Technical Data and Equipment

Tahira’s analytical laboratory is well equipped with the latest state of the art instrumentation and allows a wide range of analytical techniques to be offered to clients Our analytical activities include:

• Raw Material testing and Release
• Method development and Validation
• Finished Product Testing and Release
• HPLC, FTIR and UV/VIS Spectropho-tometer
• Stability Testing
• Microbiology
• Sterility Testing
• Packing material testing and release

Strict Quality Control is maintained in order to operate as per GLP regulations.

Listed below are some of the instruments which complete this contemporary laboratory.

• Jasco (Japan) HPLC
• Jasco (Japan) FTIR
• Jasco (Japan) UV/ Visible Spectrophotometer
• Refractometer
• Polarimeter
• Titrimeter
• Ovens (all types) and Incumators.
• All other equipment use in GLP regulated laboratory
• Stability chamber with humidity and temperature control.

Our Quality Control and Assurance department is operated by qualified and well experienced personnel having immense experience in their respective fields.