Manufacturing

Pharmaceutical contract manufacturing of sterile liquids in Baddi

From water treatment to Form-Fill-Seal filling and in-house release testing — everything that turns a formulation into a sterile, single-use vial happens inside Swanya's 3,000 sq. m vertical facility.

Contract manufacturing

Your brand, our sterile lines

Swanya offers pharmaceutical contract manufacturing in India for sterile liquids: Sterile Water for Injection, Normal Saline solution, Respules (solutions and suspensions) and FFS ampoules. Marketing companies, hospital groups, distributors and export partners supply the brand and the market; Swanya supplies the water systems, the Form-Fill-Seal lines, the clean rooms and the laboratories.

Engagements typically run as third-party manufacturing or loan-licence arrangements. The process starts with a feasibility review of your product list, fill volumes and annual quantities, followed by a site visit, artwork and specification sign-off, and a pilot batch before commercial supply.

  • Third-party & loan-licence manufacturingFor domestic marketing companies and hospital supply chains
  • Batch sizes from 500 L to 2,500 LLaunch quantities through to tender volumes on the same line
  • Stability data per ICH for your marketsRegistration support from the in-house QC laboratory
  • Open-door auditsWalk the material and personnel flows before you sign
Stainless steel FFS filling area inside the Swanya clean room

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Manufacturing capabilities & capacity

Clear solutions and suspensions, formed-filled-sealed

The manufacturing block is organised around one principle: nothing crosses that should not cross. Personnel and materials enter through separate routes. Suspensions — which need their own homogenisation controls — are handled in a separate area from clear solutions. Each product is compounded in vessels from 500 L to 2,500 L, sterile-filtered and filled on Form-Fill-Seal machines that extrude, form, fill and seal every vial in one closed cycle.

Stainless steel manufacturing vessel and piping for 500 to 2,500 litre batches
  • Separate entry for personnel and material movement
  • Separate area for handling suspensions
  • Clear solutions and suspensionsBatch capacity 500 L – 2,500 L
  • Online filter integrity testing
  • Sterilisation by autoclaving, filtration and Sterilization-in-Place (SIP)
  • FFS vials 5–30 ml · Respules 1–5 ml · FFS ampoules
Water systems

Purified Water and Water For Injection

Water is the dominant ingredient in every Swanya product, so the water plant is designed as a process line in its own right. Feed water is treated through a nine-stage train to Purified Water (60 m³/day), which in turn feeds multi-column distillation to produce WFI (48 m³/day) stored at 80 °C and above and circulated continuously. Hover or tap any stage for a one-line explanation.

Animated process flow
  1. Feed water
  2. Ozone treatment
  3. UV
  4. Multigrade filter
  5. Softener
  6. RO
  7. EDI
  8. UV
  9. Purified water

Storage tanks in cream · treatment equipment in blue · pumps marked ▶ on the connectors.

Swanya water treatment skid with control panel, pressure gauges and stainless steel piping
120m³/day
Water treatment
100m³/day
Soft water
60m³/day
Purified water
48m³/day
Water for Injection
Warehouse

cGMP warehouse with controlled storage

Every API, excipient and packaging component is received, quarantined, sampled, approved and dispensed under GMP control. Sampling happens in a dedicated booth; dispensing happens under reverse laminar airflow; consumption follows first-expiry-first-out.

  • cGMP warehouse with controlled storage capability
  • Separate sampling booth for APIs and excipients
  • Dispensing booths with RLAF (Reverse Laminar Air Flow)
  • FEFO / FIFO practice for consumption of material
Stainless steel sampling booth for APIs and excipients
RLAF dispensing booth in the Swanya warehouse
Engineering & utilities

Utilities sized with headroom

Sterile manufacturing stops when the steam, the chilled water or the power stops. Swanya's utilities are specified above current demand so that additional contract volumes can be absorbed without re-engineering the plant. Effluent is treated on site.

175TR
Chilling capacity
240CFM
Compressed air
2,000kg/hr
Boiler (1 unit)
350KVA
Installed capacity
250KVA
Generator backup
300KVA
Maximum demand
5m³/day
Effluent treatment
120m³/day
Water treatment
100%
UPS backup for QC labs
Quality Assurance

A quality system with named owners

Quality Assurance at Swanya is headed by Rokee Kumar and reports directly to the Managing Director, independent of Operations. QA owns the site's documentation system, batch record review, deviation and CAPA handling, change control, line clearance, in-process checks and the release decision for every batch.

Sterility assurance rests on three validated sterilisation routes — autoclaving, sterile filtration and Sterilization-in-Place — and on online integrity testing of every sterilising-grade filter, so each batch carries objective evidence that the filter performed as specified.

  • Batch record review and independent release
  • Deviation, CAPA and change-control management
  • Validated sterilisation: autoclaving, filtration, SIP
  • Online filter integrity testing on every batch
Quality Control

Three segregated laboratories, complete in-house testing

Quality Control, headed by Fatehyab Ali, tests every raw material, packaging material and finished product on site. Wet chemistry, instrumental analysis and microbiology are physically segregated, and the instruments run on GLP-compliant software with full power protection.

  • Segregated Wet Lab, Instrument Lab and Micro Lab
  • In-house capability for complete testing of RM, PM and FG
  • Stability studies for all markets as per ICH requirements
  • GLP-compliant instruments / software — HPLC, UV, IR
  • 100% backup by UPS
HPLC system in the Swanya instrument laboratory
Microbiology laboratory benches at Swanya
IR spectrophotometer workstation in the QC instrument lab
Stability chamber for ICH stability studies
Quality Policy

Compliance, quality and ethics — in that order, every day

Swanya Pharmaceuticals is committed to manufacturing sterile liquid products that are safe, effective and compliant with the regulatory requirements of every market it serves. To that end, we:

  1. Treat regulatory compliance as the licence to operate and never trade it for output.
  2. Manufacture only under current Good Manufacturing Practice, with validated processes and sterilisation.
  3. Test every raw material, packaging component and finished product in-house before release.
  4. Control water — Purified Water and WFI — as the most critical material in the plant.
  5. Maintain an independent Quality Assurance function with authority over batch release.
  6. Act with transparency and integrity towards patients, partners and regulators.

Approved by the Managing Director, Swanya Pharmaceuticals Pvt Ltd.

Ready to qualify a sterile-liquid partner?

Send your product list; we reply with feasibility, lead times and a site-visit invitation.

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