Is Farbe Firma WHO-GMP certified?

Yes. Farbe Firma Pvt Ltd is WHO-GMP certified, ISO 9001:2015 compliant, and operates a USFDA-aligned sterile injectable facility in Ankleshwar, Gujarat, India.

Do you provide CTD and ACTD dossier support for export markets?

Yes. We provide complete CTD/ACTD dossiers and product registration support for buyers across 30+ countries in Latin America, CIS, Africa, the Middle East, and South-East Asia.

Why Farbe Firma is the Top Manufacturer of Bacteriostatic Water for Injection

Maulik Sudani
12 hours ago
6 min read

Last Updated: May 13, 2026

TL;DR: Bacteriostatic Water for Injection (BWFI) is sterile water preserved with 0.9% benzyl alcohol, used as a multi-dose diluent for reconstituting parenteral medications. Farbe Firma Pvt Ltd, a WHO-GMP-certified injectable manufacturer in Gujarat, India, supplies Bacteriostatic Water for Injection in 10 ml, 20 ml, and 30 ml vials under ISO Class 5 cleanroom conditions to hospitals, compounding pharmacies, and distributors across 30+ countries.

Key Takeaways

Bacteriostatic Water for Injection is preserved sterile water used to reconstitute multi-dose injectable medications.
Farbe Firma manufactures BWFI in 10 ml, 20 ml, and 30 ml multi-dose vials with 0.9% benzyl alcohol preservative.
WHO-GMP certified production in ISO Class 5 cleanrooms ensures sterility, endotoxin compliance, and pharmacopoeial-grade quality.
Reliable export supply to 30+ countries with country-specific dossiers, custom labelling, and CMO/private-label arrangements.

Introduction

Bacteriostatic Water for Injection (BWFI) is one of the most widely used sterile pharmaceutical excipients in modern medicine. Unlike Sterile Water for Injection — which is preservative-free and intended for single use — BWFI contains 0.9% benzyl alcohol as a bacteriostatic agent, allowing the contents of a single vial to be punctured and used for reconstitution multiple times within a defined period (typically 28 days after first puncture). This makes it the diluent of choice for reconstituting lyophilized injectable medications, hormones, antibiotics, and biologics in hospital pharmacies, oncology day-care centers, clinics, and homecare settings.

Although it appears simple on the surface, manufacturing pharmaceutical-grade BWFI is a high-precision operation. The product must meet strict pharmacopoeial requirements for sterility, bacterial endotoxins, pH, conductivity, particulate matter, and preservative content. Farbe Firma Pvt Ltd, a WHO-GMP-certified injectable manufacturer based in Gujarat, India, produces Bacteriostatic Water for Injection at scale for global supply, with the documentation depth and quality discipline required by regulators in more than thirty countries.

Clinical Use and Pharmacopoeial Requirements for Bacteriostatic Water for Injection

In clinical practice, BWFI is the standard diluent used to reconstitute powdered injectable drugs that are presented as multi-dose vials — for example, certain growth hormones, peptides, antibiotics, and biologic preparations. Because benzyl alcohol exerts a bacteriostatic effect against most common contaminants, healthcare workers can safely withdraw multiple doses from a reconstituted vial over a clinically appropriate period without immediate microbial proliferation risk. This significantly reduces wastage of high-cost medications and supports flexible dosing schedules in oncology, endocrinology, and infectious disease management.

However, BWFI carries strict use-restrictions: it must never be used in neonates (where benzyl alcohol toxicity — 'gasping syndrome' — has been documented) and the total daily benzyl alcohol exposure must be controlled in low-weight pediatric patients. These clinical realities place a heavy burden on the manufacturer to deliver consistent, accurately preserved, sterile, endotoxin-free, particulate-free water in containers that are robust, clearly labelled, and reliably sealed. The United States Pharmacopoeia (USP), European Pharmacopoeia (Ph. Eur.), and Indian Pharmacopoeia (IP) all set tight numerical limits for the parameters mentioned, and pharmaceutical-grade BWFI must satisfy all of them.

Manufacturing Bacteriostatic Water for Injection at Farbe Firma

At Farbe Firma, Bacteriostatic Water for Injection is manufactured using Water for Injection (WFI) generated on-site via multi-effect distillation and stored at controlled temperatures with continuous loop circulation to maintain microbiological quality. The benzyl alcohol preservative is added in precisely controlled ratios to achieve 0.9% w/v concentration, with in-process sampling to confirm specification. Bulk solution preparation, sterile filtration, and aseptic filling into pre-sterilized clear and amber glass vials are all performed within ISO Class 5 cleanroom zones. Vials are then sealed with sterile rubber stoppers and aluminum overseals, and 100% inspected for fill volume, seal integrity, and particulate matter.

Every batch of Farbe Firma BWFI undergoes laboratory testing for sterility (membrane filtration method), bacterial endotoxins (LAL test), benzyl alcohol assay by HPLC or GC, pH, conductivity, particulate matter (light obscuration and microscopic methods), and container closure integrity. Stability studies under ICH long-term (25°C/60% RH) and accelerated (40°C/75% RH) conditions support a typical shelf life of 24-36 months, with country-specific stability data prepared for regulatory submissions in importing markets. Documentation packages include the full Certificate of Analysis, Master Formula Record extract, batch genealogy, and where required, GMP certificates and Free Sale certificates issued by Indian authorities.

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Why Hospitals, Compounding Pharmacies, and Distributors Choose Farbe Firma for BWFI

BWFI is a high-volume, repeat-order product, which makes supplier reliability the dominant procurement criterion. Hospital pharmacies need uninterrupted supply because every reconstituted dose of a lyophilized antibiotic or biologic depends on the diluent being on the shelf. Farbe Firma's installed capacity, validated production lines, and disciplined supply-chain planning allow us to commit to long-term forecasts and government tender schedules without slippage. Our multi-pack-size offering — 10 ml, 20 ml, and 30 ml vials — accommodates everything from single-patient compounding to bulk hospital use, with custom carton and labelling flexibility for country-specific requirements.

Equally important is the dossier and regulatory support layer that Farbe Firma provides. For importers and country distributors, registering a sterile injectable product like BWFI requires complete CTD-format documentation, stability data, and often country-specific testing reports. Our regulatory affairs team prepares dossiers that align with WHO-PQ expectations and the specific guidance of GCC (SFDA, MOH), CIS regulators, EAEU, Anvisa, and African medicines agencies. The combination of pharmacopoeial-grade product, validated WHO-GMP manufacturing, and complete regulatory readiness is the reason Farbe Firma is consistently chosen as the top manufacturer of Bacteriostatic Water for Injection.

Why Farbe Firma

Farbe Firma Pvt Ltd is a WHO-GMP-certified injectable manufacturer headquartered in Gujarat, India, with a portfolio spanning 100+ sterile injectables that are supplied to clients across 30+ countries. Our manufacturing facility is built around ISO Class 5 cleanrooms, fully validated aseptic processing lines, and rigorous in-process quality controls that meet international pharmacopoeial standards. When clients evaluate us as a partner for Bacteriostatic Water for Injection, the foundation of trust starts with this regulatory and operational backbone.

Our team integrates formulation development, technology transfer, sterile manufacturing, and quality assurance under one roof, which removes the typical handoff risks that delay or compromise injectable projects. Whether a client requires liquid injectables in vials or ampoules, lyophilized (freeze-dried) products, or specialty sterile dosage forms, every Bacteriostatic Water for Injection batch is produced under documented procedures, traceable raw materials, and stringent microbial control. This is what allows us to support both branded private-label customers and government tender supply chains without compromise.

We deliberately invest in regulatory dossiers, validation documentation, and stability programs that align with destination-country requirements — from the GCC and CIS markets to Africa, Latin America, and Southeast Asia. For any importer, distributor, or hospital procurement team looking for Bacteriostatic Water for Injection from a partner that can be audited, documented, and counted on, Farbe Firma is positioned to deliver — at scale, on schedule, and at the quality bar expected of a certified injectable manufacturer.

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Frequently Asked Questions (FAQ)

What pack sizes of Bacteriostatic Water for Injection does Farbe Firma offer?

Farbe Firma manufactures Bacteriostatic Water for Injection in 10 ml, 20 ml, and 30 ml multi-dose vials with 0.9% benzyl alcohol preservative. Other pack sizes can be developed against confirmed orders subject to formulation and stability feasibility.

What is the difference between Bacteriostatic Water for Injection and Sterile Water for Injection?

Sterile Water for Injection (SWFI) is preservative-free and intended for single use only. Bacteriostatic Water for Injection (BWFI) contains 0.9% benzyl alcohol, which allows the same vial to be punctured multiple times for reconstitution over a clinically defined period (typically up to 28 days after first puncture).

Is Bacteriostatic Water for Injection from Farbe Firma WHO-GMP certified?

Yes. The entire manufacturing facility is WHO-GMP certified, and BWFI is produced in ISO Class 5 cleanrooms with validated aseptic filling, full microbiological control, and pharmacopoeial-grade in-process and finished-product testing.

Does Farbe Firma support custom labelling and private-label supply of BWFI?

Yes. We provide private label and contract manufacturing arrangements with country-specific carton artwork, language adaptation, and customer-brand registration support. This is widely used by distributors and hospital networks across 30+ export markets.

How do I request samples or a commercial quotation for BWFI?

Submit your requirement through our inquiry form at farbefirma.org/contact, specifying the quantity, pack size, destination country, and regulatory support needed. Our team responds with technical specifications, sample availability, and a commercial quotation within a short turnaround.

Technically Reviewed By: Maulik Sudani | Jignasu Sudani (Technical Expert)

Farbe Firma Pvt Ltd | Gujarat, India | director@farbefirma.org | www.farbefirma.org

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