Sterling Healthcare is committed to contract manufacture of tablets, coated tablets, hard gelatin capsules and contract packaging of oral solid dosage formulations.

The production department has enough available installations and equipment to allow the dynamic treatment of work orders to ensure process safety.

Client requirements can be handled flexibly, whether for special operations or for complete projects. This service covers from the management of materials to the finished product, including the purchase of the active substance or any other components.

Manufacturing Facility

With a plot size of more than 21,000 square meters and a manufacturing block with a built up area of more than 5077 square meters, Sterling Healthcare stands up to be an impressive piece of engineering.

The building is RCC constructed with high density bricks infilling rendered with cement screen. All the controlled areas are supported with special slab at the plinth level with a seismic quake proof system.

The walls are plastered to smooth finish and are made non porous, free of cracks through the application of special materials (fiber mesh which has many protective features). In addition to this they are finished with the high quality paints from outside & special paints like P.U., E.P.U. and Epoxy, which are certified for antimicrobial properties.

All critical processing areas have flooring done by using ‘Polyfloor’. It is an attractive, antistatic, antiskid, high performance, heavy duty floor covering with a polyurethane reinforcement for maintenance free operation. An economical and polish free maintenance.

Coving at ceiling to wall, wall to floor and wall to wall joints ensures minimum dust accumulation and ease of cleaning.

Windows are aluminum anodized or GI oven baked powder coated double glaze flush type vacuum sealed at all joints.

The plant is well equipped with utilities like steam boilers, air compressors, DG set, purified water system along with efficient heating, ventillation and airconditioning System. In addition a dedicated effluent treatment plant caters to the requirement as per environmental and pollution norms.

Facility

• Two granulation suites (Approx. 219 Sq.m)
• Two blending suites ( Approx. 47 Sq.m)
• Four compression areas ( Approx. 130 Sq.m)
• Two encapsulation areas ( Approx. 80 Sq.m)
• Two coating areas (Approx. 124 sq.m)
• Five packaging lines : 4 Blister and 1 Bulk Packing ( Approx. 134 sq.m)

Tablet Manufacturing

• Granulation : 1200 kg / shift ( 2 granulation suites)
• Blending : 1680 kg / shift ( 2 blenders )
• Compression Machine
• Coating Machine

Capsule Manufacturing

• Blending : Octagonal blender
• Encapsulation :AF 90 T with latest features installed like Empty capsule sorter, Check weigher, Polisher, Filled Capsules and Metal detector

Packing Area

• Five packaging lines : 4 Blister and 1 Bulk Packing ( Approx. 134 sq.m)
• Two Inspection Area

Quality Control

Sterling Healthcare has a well-equipped Quality Control (QC) laboratory, which ensures that the products are pure, efficacious and are released only after thorough analysis as per stringent specifications, and procedures developed according to national & international guidelines viz. Schedule M, EU cGMP, MHRA, WHO, TGA, USFDA and other regulatory agencies.

The Quality control laboratory is handled by well-qualified and skilled personnel with the academic qualifications and experience pertaining to respective job responsibilities.

The Quality Control laboratory is equipped with sophisticated instruments like HPLCs with auto samplers and UV detectors, Infra red spectrophotometer, UV visible spectrophotometer, Karl Fischer auto titrator, TOC analyser, dissolution apparatus, melting point apparatus and all necessary state of the art instruments for analysis of finished products & in process stages. It is also backed with a segregated, complete microbiology section supporting all microbiology testing mandatory for oral solid dosage formulation requirements.

Quality Assurance

The Quality assurance department at Sterling Healthcare has a dedicated QA department that has prior experience of working in the regulated and non-regulated markets.

The key features of Quality Assurance are:
• Technology transfer through receipt of product design documents from different manufacturers
• Scale-up and validation of manufacturing process
• Preparation of validation plans for facility/ equipments/ process including cleaning
• Approval of protocols for validation of facility/ equipment/ product and process
• Controlled distribution and archiving of documents
• Control of changes made by proper change control procedure
• Approval of all documents, including cGMP training & strict adherence to SOP compliance
• Critical sampling & Record verification
• Release of batch for marketing
• Investigation of market complaints
• Stability of products as per ICH

Apart from the above there are defined processes to monitor and permanently improve quality to be implemented as desired and designed for a solid oral dosage formulation