Expert advice on cleanroom contamination control strategy
Short summary
- Personnel and garments remain the biggest variables in contamination control.
- Validated laundering and clear garment lifecycles are quick wins many sites still miss.
- Data from garment tracking helps right-size stocks and reduce risks.
- Hear practical insights from Shyam Khante, veteran pharmaceutical consultant and GMP advisor; Dr Manish Bhatkar, Founder & CEO of RedLotus Pharmtech; and Manas Kumar, Global Director of Pharma at Lindström Group.
Why this matters right now in West India
Sterile and non-sterile pharma sites across Maharashtra and Gujarat are scaling output while adapting to evolving expectations on contamination control. Quality and production teams tell us the challenge is not a lack of guidance, but the gap between written strategy and daily practice.
That gap often shows up in gowning behaviour, laundry validation, inventory control and documentation. To address it, Lindström India hosted a June webinar featuring three industry voices:
- Shyam Khante, Pharmaceutical Consultant, Trainer and Strategic GMP Advisor with more than five decades of experience in QA, QC and compliance.
- Dr Manish Bhatkar, Founder and CEO of RedLotus Pharmtech Pvt. Ltd., a global partner in GMP consulting and remediation.
- Manas Kumar, Global Director of Pharma and Director of Strategic Marketing & Business Development (APAC) at Lindström Group, focusing on contamination control and cleanroom textile solutions.
Together, they discussed how Indian pharma leaders can turn contamination control strategies into everyday habits, combining regulatory intent with operational reality.
Three highlights you can apply today
1. Turn your strategy into habits
A cleanroom contamination control strategy (CCS) is only as strong as what operators do at the locker room. Sites that succeed translate policy into simple routines: clear gowning sequences, visual cues where errors happen, and short refreshers that lock in behaviour. In the webinar, we shared the simple tells of a solid routine and how to reset expectations before deviations appear.
Inspectors today expect much more than a compliance checklist.
Shyam Khante
2. Make laundering part of the control, not an assumption
Clean garments are a control point in their own right. The most reliable programs use validated, segregated laundry processes with defined maximum wash and sterilisation cycles for each garment type, and they document the chain from soil to shipment so quality can audit it quickly. If your SOPs do not explicitly recognise laundry as a controlled step, it is an easy fix that supports Annex 1 expectations and speeds up audits.
3. Let data right‑size your garment pool
Taking guesses in garment inventory doesn’t pay off. Too few garments cause locker‑room shortages and rushed work. Too many tie up capital and hide misuse. With RFID‑based lifecycle tracking, you can see usage, wash counts and repairs per garment, then adjust pool size and rotations to maintain hygiene and availability with confidence. It is a straightforward way to cut noise and improve compliance readiness.
Inside the webinar: what the experts actually covered
From paper to performance
Inspectors are looking beyond tidy SOPs to system performance, behaviours and leadership culture. The 2022 Annex 1 revision sharpened expectations around risk‑based controls, barrier technology and a documented cleanroom Contamination Control Strategy that actually drives decisions, not just audits. In the session, we unpacked how to show that your CCS links to monitoring, deviations and investigations so it becomes a living control rather than a binder on a shelf.
CCS as a living document
A strong CCS stays aligned with reality. We discussed triggers for review such as facility modifications, product changes or trend shifts in environmental monitoring, and how cross‑functional walk‑throughs keep it relevant. Teams that connect CCS content to real deviations and EM trends find it easier to defend decisions during inspections.
Gowning discipline is an important process step
People remain the primary contamination source. The webinar covered behaviour‑based coaching, visual prompts at the point of gowning and short, frequent refreshers. Treating gowning like any other GMP step, with clear KPIs and observation rounds, helps reduce variability across Grade B to D areas.
Investigations move beyond “human error”
We explored why shallow root‑cause analysis leads to repeat events, and how structured tools and trend reviews prevent the “quick fix” loop. Practical point: let real events trigger requalification or procedural updates, instead of waiting for the calendar.
If the company has weak investigation and weak CAPAs, it’s direct indicator of that the organization is interested only in fixing symptoms but not improving the systems.
Mahish Bhatkar
Sites still struggle with these common gaps
We summarised recurring gaps we see on Indian shop floors: weak risk management, poor gowning discipline, HVAC or airflow visualisation issues, fragmented CCS and EM linkages, media fills that do not reflect real interventions, and data integrity lapses.
What you will gain by watching the webinar recording
In the full webinar:
- Mapping of where contamination risk moves with people and textiles. Focus your effort where it pays back fastest.
- A practical view of validated laundering and audit-ready documentation.
- Examples of how digital tracking supports availability and reporting for procurement and quality.
The webinar provides tactical adivce, ready to implement. The article you are reading is a short recap only.
For whom?
- Procurement leaders who prefer predictable service models with traceability and reports on demand
- Quality managers who need defensible, documented gown and laundry controls
- Plant managers who want fewer line stops due to garment shortages
Lindström as a relibable partner in Contamination control strategy
Pharma customers choose us for cleanroom garment services that combine validated laundry processes, hygienic handling and full lifecycle tracking. Our service includes provision, laundering, repair and proactive replacement of garments, with RFID‑based traceability and non‑editable reports that simplify audits. That means you get reliable availability, clear documentation and one accountable partner. We design garments to relevant cleanroom standards such as IEST‑RP‑CC003 and operate processes aligned with EN 14065.
About Lindström India
We provide end‑to‑end cleanroom garment services for regulated manufacturers, combining compliant laundering, lifecycle management and digital traceability, with regional delivery and support.
Questions & answers
Is this relevant if we run mostly Grade C or D areas?
Yes. The biggest gains come from consistent gowning behaviour and validated laundering in every grade. These controls reduce variability across the whole site, not just aseptic zones.
How do you prove laundering is validated?
Through documented programmes aligned with EN 14065 for biocontamination control, segregated barrier processes, and defined garment lifecycles with test data. Your quality team can review these records during qualification and audits.
What if we already manage garments in‑house?
Use the webinar framework to audit your current process. Many teams adopt RFID lifecycle tracking and structured repair rules to remove guesswork and improve availability even before considering outsourcing
Do we need isolators to satisfy Annex 1 expectations?
Barrier technology reduces risk where feasible, but regulators expect a risk‑based rationale. If isolators are not in scope, you still need strong gowning, CCS linkage to monitoring and robust investigations to show control.
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