Schedule M • WHO-GMP • FDA-Ready • Seamless CIPY Cleanroom Floors by Pidilite Authorized Applicator • 500+ Projects Delivered
In the pharmaceutical manufacturing environment, the floor is not simply a structural surface — it is an active component of the contamination control system that protects the safety and efficacy of medicines produced in the facility. Regulatory frameworks from India's Schedule M (Good Manufacturing Practices under the Drugs and Cosmetics Act), the World Health Organization's WHO-GMP guidelines, and the US FDA's 21 CFR Part 211 and Part 820 requirements all set explicit requirements for pharmaceutical facility floors. Understanding why these requirements exist is essential to specifying the right flooring system.
The primary concern in pharmaceutical manufacturing is cross-contamination — the inadvertent transfer of microbial organisms, particulate matter, or chemical substances into products being manufactured. Floors that have joints, cracks, porous surfaces, or right-angle wall junctions create refuges where microorganisms can colonise, particulates can accumulate, and cleaning agents cannot effectively reach. In oral solid dosage manufacturing, contaminated floors generate dust that can migrate into tablet compression or capsule filling operations. In sterile manufacturing, floor contamination represents a direct product sterility risk. In API manufacturing, residue accumulation on floors can lead to cross-contamination between different API batches — a GMP deviation with potentially serious regulatory consequences.
Schedule M of India's Drugs and Cosmetics Act specifically requires that pharmaceutical manufacturing premises have floors of smooth, hard, washable construction; free of cracks and open joints; easy to clean; and resistant to the disinfectants and cleaning agents used. The requirement for seamless construction — achieved through CIPY self-levelling epoxy systems with integral cove skirtings — directly addresses the contamination control needs of pharmaceutical manufacturing. A conventional tile floor, regardless of how well-maintained, cannot meet these requirements: the grout lines between tiles are a perpetual source of contamination risk that no cleaning regime can fully eliminate.
WHO-GMP guidelines add a further dimension: floors in manufacturing areas should not only be smooth and washable but should be resistant to the specific chemical agents used in cleaning-in-place and sterilisation-in-place operations — typically including dilute hypochlorite, quaternary ammonium compounds, phenolics, isopropyl alcohol, and hydrogen peroxide vapour. These disinfection chemicals can rapidly degrade inadequately specified flooring systems, leading to surface pitting, cracking, and eventual delamination that creates the very contamination refuges the system was meant to prevent.
The third major consideration for pharmaceutical flooring is maintenance of cleanroom classification. In classified cleanrooms (ISO Class 5–8 / GMP Grade A–D), the floor surface must not contribute to particle generation. Standard concrete — even sealed concrete — generates fine particulates from normal surface wear and from the micro-fracturing of surface laitance under foot traffic. CIPY self-levelling epoxy floors are completely non-particulate-generating, providing a stable, chemically inert surface that actively supports cleanroom classification maintenance by eliminating one of the potential sources of particle generation in the controlled environment.
Sri Sai Technologies has been installing CIPY pharmaceutical flooring systems across India's pharmaceutical manufacturing sector for over 15 years. As an Authorized Applicator of CIPY Flooring Systems by Pidilite Industries, we bring not only the right products but also the right application discipline, regulatory awareness, and contamination control protocols for pharmaceutical environments. From WHO-GMP-audited bulk drug manufacturers in Hyderabad to US FDA-inspected sterile injectable plants in Ahmedabad, our CIPY pharma floor installations have successfully passed regulatory inspection across India's most demanding pharmaceutical facilities.
Best for: General manufacturing areas, formulation, packaging, corridors, gowning rooms, and all GMP production areas.
The standard pharmaceutical floor system. CIPY two-component self-levelling epoxy applied at 2–3mm provides a seamless, mirror-smooth surface with exceptional chemical resistance. Integral cove skirting formed using CIPY epoxy mortar and finished with the self-levelling topcoat eliminates floor-wall junctions — the most critical GMP compliance feature. Available in light grey or any RAL colour for cleanroom classification zone identification.
Best for: Autoclave discharge areas, CIP/SIP stations, steam-sterilised equipment areas, washrooms, and any zone subject to repeated high-temperature water or steam exposure.
Polyurethane flooring systems by CIPY Pidilite provide superior thermal shock resistance compared to standard epoxy — critical in pharmaceutical areas where autoclaves, steam sterilisers, and CIP systems generate repeated thermal cycling from ambient to 120°C+. PU systems remain flexible under thermal stress, preventing the cracking and debonding that affects rigid epoxy systems in these zones.
Learn More →Best for: API powder handling, tablet compression, capsule filling, electronic weighing rooms, and any area where static charge accumulation risks product contamination or ignition of flammable solvents.
CIPY ESD flooring systems provide controlled electrostatic dissipation to earth for pharmaceutical powder processing areas. Static charge accumulation in tablet compression and API powder handling can cause powder agglomeration, accurate weight variation, and dust ignition risk with flammable solvents. CIPY ESD systems meet IEC 61340 requirements and integrate with bonded earthing systems through the facility.
Learn More →Best for: QC laboratories, analytical chemistry labs, microbiology labs, reagent storage areas, and solvent handling zones.
Laboratory floors are exposed to a wide range of aggressive chemicals — concentrated mineral acids (HCl, H₂SO₄, HNO₃), strong alkalis (NaOH, ammonia), organic solvents (acetonitrile, methanol, chloroform), and buffers at extreme pH values. CIPY chemical-resistant epoxy and novolac epoxy systems provide resistance to this complex chemical environment, with cove skirting for seamless hygiene compliance.
Learn More →Best for: ISO Class 5–7 cleanrooms (GMP Grade A/B/C), sterile injectable filling rooms, lyophilisation areas, and any area requiring the highest contamination control standard.
CIPY ultra-smooth self-levelling epoxy systems with high-gloss finish provide Ra surface roughness values ≤ 1 µm — critical for sterile cleanroom classification maintenance. Applied under strictly controlled contamination conditions using cleanroom-protocol application procedures, with HEPA air filtration during application to prevent particle ingress during the cure phase.
Best for: Raw material warehouses, finished goods stores, cold chain storage, quarantine areas, and dispatch zones within pharmaceutical facilities.
Pharmaceutical warehouse floors require dust-free, easily cleaned surfaces compliant with GMP storage requirements. CIPY high-build epoxy or self-levelling systems provide non-porous, easily audited storage floors that meet the material cleanliness standards of GDP (Good Distribution Practice) and GMP raw material storage requirements.
Schedule M (revised) of India's Drugs and Cosmetics Act mandates that pharmaceutical manufacturing premises have floors of smooth, impervious construction that are easy to clean, resistant to disinfectants, and free of cracks, joints, and open seams that could harbour contamination. CIPY self-levelling epoxy systems with integral cove skirtings installed by Sri Sai Technologies fully satisfy these Schedule M floor requirements.
WHO's Good Manufacturing Practices guidelines (Technical Report Series 961, 986, and related annexures) specify requirements for pharmaceutical facility surfaces including floors — emphasizing cleanability, chemical compatibility with disinfection agents, non-shedding characteristics, and visual inspectability for cleanliness verification. CIPY pharmaceutical floor systems are specifically formulated to meet these WHO-GMP surface performance criteria.
US FDA's current Good Manufacturing Practice regulations (21 CFR Part 211) for finished pharmaceuticals and Part 820 for medical devices require that facility surfaces be of smooth, easily cleanable construction. CIPY self-levelling epoxy floors used in FDA-inspected Indian pharmaceutical export facilities consistently pass FDA inspection — a testament to the system's compliance performance under the most demanding global regulatory standard.
| Parameter | CIPY Self-Levelling Epoxy (2–3mm) | CIPY PU Flooring (3–4mm) | CIPY Novolac / Lab System (3–5mm) |
|---|---|---|---|
| System Thickness | 2 – 3 mm | 3 – 4 mm | 3 – 5 mm |
| Compressive Strength | ≥ 60 N/mm² | ≥ 45 N/mm² | ≥ 65 N/mm² |
| Pull-off Adhesion | ≥ 1.8 N/mm² | ≥ 1.5 N/mm² | ≥ 2.0 N/mm² |
| Shore D Hardness | ≥ 80 | 60–75 | ≥ 82 |
| Surface Roughness (Ra) | ≤ 3 µm (≤1 µm high gloss) | ≤ 5 µm | ≤ 3 µm |
| Chemical Resistance | Dilute acids/alkalis, disinfectants, IPA | Dilute acids/alkalis, thermal shock | Conc. acids/alkalis, solvents, aggressive chemicals |
| Thermal Shock Resistance | Moderate (up to 60°C) | Excellent (up to 100°C+ cycling) | Good (up to 70°C) |
| Temperature Range (service) | -10°C to +60°C | -20°C to +100°C | -10°C to +70°C |
| Joint Construction | Seamless (cove skirting available) | Seamless (cove skirting available) | Seamless (cove skirting available) |
| GMP Compliance | Schedule M / WHO-GMP / FDA | Schedule M / WHO-GMP | Schedule M / WHO-GMP / FDA |
| Light Foot Traffic (cure) | 24 hours | 24 hours | 24–48 hours |
| Full Service Cure | 5–7 days | 5–7 days | 7 days |
| Expected Service Life | 10–15 years | 10–15 years | 12–18 years |
* All values for CIPY products by Pidilite Industries applied per manufacturer specification by Sri Sai Technologies certified applicators. Actual performance depends on substrate condition, ambient conditions, and maintenance practices.
CIPY self-levelling epoxy creates a completely seamless floor with no joints, grout lines, or crevices — eliminating all bacteria and contamination harbourage points required by Schedule M and WHO-GMP.
Seamless curved cove transition between floor and wall surface — the most critical GMP compliance feature, eliminating the right-angle floor-wall junction where contamination accumulates.
High-gloss CIPY self-levelling epoxy achieves surface roughness values well below the GMP threshold — facilitating thorough cleaning and supporting cleanroom classification maintenance.
CIPY epoxy floors are resistant to the full range of pharmaceutical disinfection agents — hypochlorite, IPA, QAC compounds, hydrogen peroxide, phenolics — without surface degradation or discoloration.
Once cured, CIPY epoxy is completely non-particulate — generating zero floor-borne particles under normal foot traffic. Critical for maintaining classified cleanroom environmental standards.
CIPY chemical-resistant systems handle the full range of pharmaceutical laboratory chemicals — from concentrated acids and alkalis to organic solvents and buffers — without surface attack or degradation.
CIPY ESD flooring available for API powder processing, tablet compression, and other static-sensitive pharmaceutical manufacturing zones — meeting IEC 61340 static dissipation requirements.
CIPY self-levelling epoxy available in any RAL colour — enabling GMP zone identification (different colours for different cleanroom grades, dedicated zones, and material flow pathways).
CIPY pharmaceutical epoxy systems consistently deliver 10–15 years of GMP-compliant performance, dramatically reducing the total cost of facility floor compliance over the plant lifecycle.
We provide full application records, material certificates (Pidilite batch traceability), and QC inspection reports to support your regulatory audit files and qualification documentation (DQ/IQ evidence).
CIPY PU systems for autoclave and CIP/SIP areas resist repeated thermal cycling from ambient to 100°C+ without cracking or delaminating — maintaining the seamless floor integrity required for GMP compliance.
Applied by Sri Sai Technologies as an Authorized CIPY Applicator, your pharma floor carries Pidilite's manufacturer warranty — the most comprehensive quality guarantee available in India's pharmaceutical flooring market.
API synthesis, granulation, blending, tablet compression, capsule filling, coating. CIPY self-levelling epoxy with integral cove skirting — smooth, washable, disinfectant-resistant. ESD in static-sensitive production zones. Colour-coded for different product areas.
Sterile filling, lyophilisation, aseptic processing. Ultra-smooth CIPY self-levelling epoxy (Ra ≤ 1 µm) applied under contamination-controlled conditions. High-gloss finish for visual cleanliness inspection. Seamless cove skirting and integrated drain surrounds.
Chemical analysis, microbiology, stability testing. CIPY chemical-resistant novolac epoxy for resistance to concentrated acids, alkalis, organic solvents. Integral cove skirting. Anti-slip areas under wet bench conditions. ESD in electronic weighing areas.
Personnel movement corridors, gowning rooms, airlocks, and change rooms connecting GMP zones. CIPY self-levelling epoxy with cove skirting. Clearly defined cleanroom grade boundaries through colour change or physical demarcation lines embedded in the floor system.
GDP-compliant raw material storage, quarantine areas, and finished goods dispatch. CIPY high-build epoxy or self-levelling system for clean, easily auditable storage floors. Dust-free surface compliant with GMP material storage and GDP requirements.
Equipment washrooms, CIP stations, autoclave areas, steam steriliser discharge zones. CIPY PU flooring for thermal shock resistance. High-aggregate anti-slip surface. Integral drainage channels with CIPY-compatible sealant joints. Cove skirting throughout.
Installing flooring in an active or newly qualified pharmaceutical facility requires contamination control protocols that go far beyond standard industrial flooring application. Our team is specifically trained and equipped for pharmaceutical environment work.
We work with your QA team to prepare a comprehensive installation plan that includes contamination risk assessment, personnel flow control, material entry protocols (double-bagging CIPY materials for cleanroom entry), waste management procedures, and documentation requirements for your Design Qualification (DQ) and Installation Qualification (IQ) files. All CIPY products are supplied with certificates of analysis and material safety data sheets for regulatory file inclusion.
Before substrate preparation begins, temporary contamination barriers (sealed polyethylene sheeting to ceiling height) are installed to isolate the work zone from adjacent GMP areas. HEPA-filtered negative pressure units (where the facility is operational) prevent construction dust from migrating to clean zones. All personnel entering the work zone follow your facility's gowning protocols for the relevant cleanroom grade.
Diamond grinding is the preferred surface preparation method for pharmaceutical cleanroom areas — generating far less airborne particulate than shot blasting. HEPA vacuum extraction is used during all grinding operations. All concrete dust is collected and disposed per your facility's waste management procedures. Moisture content and substrate condition are documented for the IQ file.
CIPY epoxy mortar is applied at the floor-wall junction and profiled to the specified cove radius (typically 50mm radius, 100–150mm height). The cove is formed to a smooth, consistent radius using purpose-made cove profile tools, ensuring no flat areas or irregular radii that would compromise cleanability. This step is completed before the self-levelling floor pour so the cove and floor are monolithic in construction.
CIPY epoxy primer is applied at the specified coverage rate using low-emission, pharmaceutically compatible solvents. In sterile area installations, solvent-free or ultra-low-VOC CIPY primer formulations are used to minimize atmospheric contamination during application. Primer consumption and coverage are recorded for the IQ documentation file.
CIPY self-levelling epoxy is mechanically mixed to exact specification (ratio, mixing time, temperature) and poured onto the primed substrate. A precision spiked roller is used to release entrapped air bubbles and ensure a uniform, flat surface. For high-specification cleanroom areas, an additional pin-hole elimination coat may be applied after the first. Wet film thickness is checked at multiple locations to verify uniformity across the entire floor area.
Final quality control inspection includes: adhesion pull-off testing (minimum 5 test points per 200 sq.m.), holiday/pinhole detection using wet sponge test, thickness verification (Elcometer or DFT gauge), surface roughness measurement (profilometer), and visual inspection under oblique lighting for uniformity. A comprehensive QC report is produced, including all CIPY batch certificates, application records, and inspection results — constituting the IQ (Installation Qualification) evidence for your regulatory files.
Challenge: Refurbishment of an existing WHO-GMP-certified API manufacturing facility requiring complete floor replacement during a planned regulatory maintenance shutdown. The existing floor had tile joints that failed Schedule M inspection. The refurbished floor needed to support a WHO-GMP re-certification audit within 8 weeks of project completion.
Solution: CIPY self-levelling epoxy system with integral cove skirting across all production areas. CIPY chemical-resistant novolac epoxy in QC laboratories. CIPY PU system in CIP and autoclave areas. Full IQ documentation package including CIPY batch certificates and QC inspection records prepared for audit submission.
Outcome: 60,000 sq.ft. completed in 18 working days. WHO-GMP re-certification audit passed without any flooring-related observations. Client's QA manager confirmed all Schedule M flooring requirements were clearly met. Ongoing relationship — Sri Sai Technologies has since completed flooring for this client's two new manufacturing blocks.
Challenge: New sterile manufacturing facility preparing for US FDA pre-approval inspection. All floor surfaces in ISO Class 7 and 8 areas required Ra ≤ 3 µm; sterile core areas required Ra ≤ 1 µm. Full contamination control during installation was mandatory — the facility was to be qualified immediately after construction completion.
Solution: CIPY ultra-smooth self-levelling epoxy with high-gloss topcoat in sterile core areas (Ra ≤ 1 µm achieved). Standard CIPY self-levelling (Ra ≤ 2 µm) in support cleanrooms. CIPY PU system in sterile equipment washrooms. Complete cleanroom installation protocol including HEPA vacuum extraction, gowning controls, and pharmaceutical-grade material management throughout.
Outcome: Project completed to schedule. All Ra surface roughness measurements verified by independent testing. US FDA pre-approval inspection passed — no observations related to facility surfaces. Floor has now supported 3 consecutive successful FDA inspection cycles. Client has referred Sri Sai Technologies to three other FDA-regulated manufacturers in their network.
Challenge: Multi-zone pharmaceutical R&D facility requiring five different floor specifications across a single floor plate — standard GMP production labs, solvent handling labs (chemical resistant), electronics characterisation area (ESD), autoclave room (PU), and office/meeting zone — all with seamless transitions between zones.
Solution: Full CIPY floor system portfolio deployed in a single integrated project: CIPY self-levelling epoxy (production labs), CIPY novolac epoxy (solvent labs), CIPY ESD system (electronics area), CIPY PU flooring (autoclave room), and CIPY high-build epoxy (office zones). All zones connected with seamless CIPY transitions and colour-coded for area identification.
Outcome: All five floor systems installed in 12 working days in a coordinated multi-system programme. All specifications verified by QC inspection. Client's facility manager cited the single-contractor, multi-system capability as a key advantage — eliminating coordination complexity and ensuring seamless system transitions across zone boundaries.
Schedule M of India's Drugs and Cosmetics Act requires that pharmaceutical manufacturing area floors are smooth, hard, impervious, easy to clean, and resistant to disinfectants. There must be no cracks, open joints, or floor-wall junctions that can trap contamination. CIPY self-levelling epoxy with integral cove skirting directly meets all these requirements, making it the most commonly specified floor system for Schedule M compliance in Indian pharmaceutical facilities.
Yes. CIPY pharmaceutical flooring systems have been successfully installed in numerous WHO-GMP-certified and US FDA-inspected Indian pharmaceutical manufacturing facilities. The seamless, non-porous, chemically resistant CIPY self-levelling epoxy — with integral cove skirting — meets the surface requirements of both WHO-GMP guidelines and US FDA 21 CFR Part 211 facility requirements. Sri Sai Technologies provides full IQ documentation to support regulatory inspection files.
A cove skirting is a curved, seamless transition between the floor surface and the wall, formed using CIPY epoxy mortar and finished with the same CIPY self-levelling topcoat as the floor. It typically has a 50mm radius and rises 100–150mm up the wall. Cove skirtings eliminate the right-angle floor-wall junction — a critical contamination harbourage point where bacteria, dust, and particulate accumulate in conventional construction and cannot be effectively cleaned. They are a mandatory GMP requirement for pharmaceutical production areas under Schedule M and WHO-GMP guidelines.
For general pharmaceutical production areas, Ra ≤ 3 µm is the standard requirement to facilitate effective cleaning and disinfection. For sterile manufacturing cleanrooms (ISO Class 5–7 / GMP Grade A/B), Ra ≤ 1 µm may be specified. CIPY high-gloss self-levelling epoxy systems installed by Sri Sai Technologies consistently achieve Ra values below both thresholds — verified by profilometer measurement and recorded in our IQ documentation.
Yes, through phased installation with appropriate contamination controls. We regularly install pharmaceutical floors in areas adjacent to or within operating GMP facilities. Full contamination barriers, HEPA-filtered negative pressure units, gowning protocols for our installation teams, and controlled material entry procedures are implemented. We work with your production planning and QA teams to schedule installation during planned maintenance periods or in sections that maintain operational continuity.
The CIPY product range used for pharmaceutical flooring includes: CIPY Epoxy Primer (solvent-free formulation for pharma areas), CIPY Epoxy Mortar (for cove skirting formation), CIPY Self-Levelling Epoxy (main floor system — available in multiple colours), CIPY PU Flooring (for thermal shock areas), CIPY Novolac Epoxy (for laboratory chemical-resistant systems), and CIPY ESD System (for static-sensitive powder processing areas). All sourced through Pidilite's authorized supply chain with full batch traceability documentation.
Yes. We provide a comprehensive documentation package with every pharmaceutical flooring installation, including: CIPY product batch certificates (from Pidilite Industries), material safety data sheets, application records (mixing ratios, coverage rates, ambient conditions, cure times), QC inspection reports (adhesion test results, thickness measurements, surface roughness values), and photographic records. This documentation constitutes the Installation Qualification (IQ) evidence for your regulatory file and is prepared in a format compatible with pharmaceutical GMP documentation requirements.
Pharmaceutical GMP epoxy flooring using CIPY systems typically ranges from ₹180–₹280/sq.ft. for standard production areas with self-levelling epoxy and cove skirting, to ₹300–₹500+/sq.ft. for sterile cleanroom areas with high-gloss specification, ESD systems, and full IQ documentation. PU systems for thermal shock areas are ₹250–₹400/sq.ft. Contact Sri Sai Technologies for a free site survey and detailed area-by-area quotation.
CIPY pharmaceutical epoxy flooring systems typically deliver 10–15 years of GMP-compliant performance under normal pharmaceutical operational conditions — including regular cleaning, periodic disinfection, and light personnel and trolley traffic. The type and frequency of disinfection agents has the greatest impact on longevity; IPA and quaternary ammonium compounds are generally well-tolerated by CIPY systems, while highly concentrated oxidising disinfectants should be used per guidelines to preserve surface quality over the system's full service life.
Yes. Sri Sai Technologies has extensive experience working within active pharmaceutical manufacturing environments — including GMP-compliant personnel access procedures, contamination control protocols, material double-bagging for cleanroom entry, HEPA vacuum extraction during substrate preparation, and coordination with plant QA and production teams. We understand that in a pharmaceutical facility, the installation process itself must meet contamination control standards — not just the finished floor.
Our technical team will visit your pharmaceutical facility, assess your GMP requirements and substrate conditions, and prepare a complete CIPY floor system specification — with full IQ documentation support and a transparent, detailed quotation.