We believe that design of finished dosage form facility is more of an art than just pure engineering and science.
It requires a clear understanding of not only the process but also requires consideration of cGMP regulations, regulatory compliance, local statutory norms, quality management and special care for cross contamination, gowning, EHS, cleaning, air flow control and water purification.
Spectrum has successfully executed 150+ formulation facilities of various dosage forms. Spectrum is involved in designing of Formulation Facilities right from the conceptual design stage, capacity planning, equipment selection, to final qualification and validation of facility. We have executed more than One Hundred Fifty projects of Formulation Facilities. Spectrum has separate team of experts and projects to execute various formulation facilities of different forms like Tablets, Injectables, Eye and Nasal Drops, Semi-Solids, Ointments and Creams.
Spectrum has successfully completed numerous sterile and non-sterile Formulation facilities, across India and Globe. Over 40 facilities designed and engineered by Spectrum, have received approvals from US FDA, UK MHRA, EU GMP, Australian TGA, Brazil ANVISA, South African MCC, WHO, etc
We have experience in setting up below facilities -
- Dry Powders (In Sachets & Bottles)
- Liquid Syrups & Suspensions
- Liquids Injectables in Vials and Ampoules
- Liquids Injectables in Pre-filled Syringes, Cartridges
- Lyophilized Injectables in Vials
- Dry Powder Injectables in Vials
- Large Volume Parenteral (Infusions) filled using Blow-Fill-Seal and Form-Fill-Seal technologies
- Soft Gelatin Capsules, Twist off Capsules & Gummies
- Metered Dose Inhalers
- Nasal Sprays
- Dry Powder Inhalers
- Ointment (Sterile & Non-Sterile)
- Eye, Ear & Nasal Drops