Infrastructure

Quality Control

Quality Control Department is mainly concerned with analytical activity and verifying the quality of material being used in the manufacture of the product. The department mainly constitutes of Chemical /Instrumentation Analysts and Microbiologists. Materials that undergo analysis are API’s Excipients, Primary Packing Materials, Secondary Packing Materials & items that are used in the maintenance of the utilities. To check the quality of these materials, highly sophisticated, latest & modern equipment are used which are GLP & 21CFR compliant. These equipment’s work with password protection. Dep’t is mainly involved in Validation/Verification of Analytical Methods so that the right procedure is used to ascertain the quality of the material. Some of the equipment’s that are routinely used in the laboratory are Analytical Balances with high precision, UV/VIS Spectrophotometer, FTIR Spectrometer, TOC, HPLC, GC etc. along with other routine analytical equipment.

Analysts Microbiology :-

A very important department in any Sterile set up. Department is run by efficient Microbiologists. Activities like EVM, Sterility Test, BET, MLT and Maintenance of Cultures are carried out. Method Validation with respect to MLT, BET and Sterility are performed. Microbiologists are mainly responsible for the maintenance of classification of the area with respect to Viable & Non Viable particulate matter. Responsible to carry out the Media Fills to assure that the Process, Equipment, Area, Personnel and the Practices are all in compliance state to assure the product sterility.

Quality Assurance

Quality Assurance is the backbone of any Pharmaceutical Industry. The Team consists of Pharmacists /Scientists/Regulatory Personnel. They certify “that the product is thoroughly reviewed with the executed batch record and confirm that the product was manufactured under GMP conditions. They also confirm that the sterilization, laboratory records, in process records and other data pertaining to the product confirm the product to be acceptable for release and distribution to the market”. The Quality Assurance team is mainly involved in maintaining the quality of the product manufactured, GMP, GLP, Training, Various Investigations of the product in question & Validations.

Manufacturing

All products are processed in accordance with Master Formula Record. The activities are documented in the Batch Manufacturing Record and the Batch Packing Record. On line documentation are carried out.

All the API, Excepients, Primary packing materials, Filters & Tubing’s required to manufacture the product are procured from Approved Vendors. All the manufacturing activities are carried in house and all the relevant documents related to process are enclosed with the BMR for authenticity. The equipments used for the process are all well qualified and calibrated at pre defined intervals.

The processing of the product is carried in Class C, where as the filtration & filling of the product is carried in Class A/B. The washing and sterilization of the primary packing components are carried in Class D areas. Sterilization of these primary packing components are done by Autoclave/Sterilizing Tunnel.

All critical activities are carried under LAF’s. During Filtration, Pre & Post bubble point tests are performed to check the integrity of the filters. As per the need of the product, pre and post gassing of Nitrogen is performed on the products during filling. Continuous Particle Monitoring is performed during filling.

Products which are terminally sterilized are also processed as aseptic product with same procedure as an aseptic product is processed.100% visual inspection is performed on the filled units using automatic visual inspection machine. The rejects are classified and documented. Visually inspected vials are further processed to pack using automated labeling & cartoning machines.

The finished products are transferred to bonded ware house for further release for distribution by QA. Media Fills are performed at predefined intervals to assess the filling line qualification. Recovery Studies (Sweep Time Study) are performed to establish the time taken to retain the normalcy of the class after turbulence.

HVAC System

Totally there are 50 Air Handling Units (27 AHU, 13 Exhaust Systems & 10 Ventilation Units).

All the HVAC systems are well qualified and are calibrated at definite intervals with respect to Pressure Differentials, Air Changes, Velocity, Particulate matter, Air Flow Pattern, Temp & RH to maintain Clean Room Class of ISO-5, ISO-6. ISO-7 & ISO-8 and to maintain the temperature of NMT 25°C and relative humidity of NMT 55% RH and to eliminate any possible potential cross-contamination from one processing area to another.

Terminal HEPA are with 99.997% efficiency. Regular smoke studies are carried out to determine the flow pattern and no turbulence are generated at the LAF stations. An Effluent Treatment Plant (ETP) takes care of the in-house waste material system and also manages waste materials according to the government’s waste management guidelines.

With the aim to cope with the challenges of globalization and set new milestones in the SVP production, SALSL has crossed the set boundaries and partnered with some of the leading pharmaceutical organizations.

Dry & Wet Utensils

The main source of water to the plant is from underground. The water is extracted thru bore well and is pumped to an underground tank which has a capacity of 135 KL. From the underground tank the water is pumped to an over head tank. From the over head tank, the water passes to the Softener Plant where the water gets softened and is used for Boiler, Chillers & Cooling Towers.

This softened water enters the Purification of Water System. After the water is purified, this water is stored in SS 316L tank with a capacity of 5KL at an ambient temperature under constant circulation loop.

Purified Water is used for preliminary washing of all manufacturing equipments & dress materials. This Purified Water acts as input water for the generation of Water for Injection. The WFI is generated with the help Multi Effect Distillation Still which has 5 Columns. The WFI so generated is stored in SS 316L tank with a capacity of 3KL at an elevated temperature of NLT 80°C under constant circulation loop. The return loop is monitored for the Temperature (NLT 70°C) & Conductivity (NLT 1.3µsim).

WFI is used in the manufacture of Products, Final rinse of all manufacturing equipments, Dress Materials & Quality Control Equipments. The Purified Water acts as input water for the generation of Pure Steam. Pure Steam is generated with the help Pure Steam Generator. The Pure Steam is used in Autoclaves for the sterilization of materials that come directly in contact with the products.

The Whole Water System is well Qualified with respect DQ, IQ, OQ & PQ. The Water System stands Validated for Phase1, Phase2 & Phase 3 which is ongoing. All types of water are periodically monitored for the seasonal variations. Based on these Alert & Action limits, Regeneration & Sanitization frequency have been established.

NITROGEN PLANT:

The Nitrogen Gas generated is of 99.99% purity which is generated from Compressed Air employing de-oxo or purification units. With this system a very high purity of Nitrogen, free from moisture & hydrogen, is generated. The equipment’s used in the plant are in accordance with ASME/IS 2825.The capacity of generation of Nitrogen is 10 m³ /Hour.

The special features of the Nitrogen Gas Plant:

On site Nitrogen Generation from compressed Air
Online Oxygen Analyser
Low Cost Nitrogen Generation
Refrigeration dryer employed for avoiding purge air loss.

COMPRESSED AIR:

The compressed air available at site is oil free, compressed at 40 °C and 7.5 kg/cm².Compressed Air Treatment (CAT) unit is installed to generate high quality compressed air for the Nitrogen Plant.

CAT comprises of 5 stage purification

An after cooler
Air Receiver – Wet
Moisture Separator – Mechanical Type
Candle Filter
Fine Filter – For Dust

At the CAT outlet, compressed air is at atmospheric temperature and free from oil, dust and physical moisture. This acts as an in feed to the Nitrogen Generation Plant.