Oncology Injection Manufacturing

Manufacturing

Neiss Labs 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 to enable the maintenance of the utilities without disturbing the sterile areas below.

The manufacturing areas at Neiss labs 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.

Formulations Manufactured

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.

The combination of man, material, machinery and systems enables Neiss Labs 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.

Quality

Being in the business of healthcare products, Neiss Labs acknowledges quality as the first and the foremost important aspect. The key ingredients of manufacturing process clearly indicate the Neiss Labs’ commitment towards quality, they are…

  • Exhaustive Specifications for Inputs & Outputs
  • Validated Manufacturing Methods
  • Stringent In-process Controls
  • Validated Batch Manufacturing Procedures
  • Validated & Approved Analytical Procedures
  • Independent Quality Assurance Department
  • Elaborate Standard Operating Procedures