The Technical Resource Library
By SOSCleanroom — practical training material for cleaner outcomes
Cleanroom Cleaning & Disinfection Training Guide
How to build repeatable results with wiping, mopping, isolator cleaning, swab sampling, and risk-based disinfection.
Why this guide exists
Cleanroom performance is rarely “one big thing.” It is the sum of small, repeatable behaviors: how a wiper is folded, how strokes overlap, how contact time is achieved in practice, how mop covers are changed, how corners are swabbed, and how materials enter and exit controlled spaces. This guide consolidates field-proven methods from our training materials into one customer-facing how-to resource, with selection logic and documentation tips you can adapt to your facility.
SOSCleanroom’s role is straightforward: we supply best-in-class cleanroom consumables with fast shipping, excellent customer service, fair pricing, and continuity of supply — so your team can execute without worrying about stockouts, substitutions, or last-minute scrambles. We have supported controlled environments for more than 40 years and have earned multiple supplier excellence awards through disciplined service and reliability.
On this page
- Core cleanroom controls that drive outcomes
- Wiping technique: the highest-impact details
- Wiper selection: substrate, edge, cleanliness, and format
- Cleanroom-grade alcohol: why sterile, controlled alcohol is the standard
- Sporicidal disinfectants: when they are needed and how to use them
- Mopping technique: walls and floors without recontamination
- Isolator cleaning: controlled entry, systematic wiping, corner work
- Swab sampling: cleaning validation and residue recovery basics
- Compatibility charts: avoiding degraded materials and hidden residues
- SOP suggestions: standard and advanced building blocks
- Compliance context: ISO 14644, USP <797>, USP <800>, and audit defensibility
- What we see and have learned from our customers
- Source basis
Core cleanroom controls that drive outcomes
Risk statement: Cleanroom performance is ultimately a risk-management problem: you are controlling viable and nonviable contamination, chemical residues, and electrostatic events across products, processes, and people — under a defined compliance scope.
Risk factors that determine the control strategy
- Product risk: Sterile vs. non-sterile needs, sensitivity to endotoxins/pyrogens, particles, residues, and ESD. Higher sensitivity requires tighter acceptance criteria and higher discipline in materials, monitoring, and response.
- Process risk: Open manipulations, high-touch steps, transfers, changeovers, and maintenance intrusions are where contamination is introduced. These moments drive engineered airflow needs and validated cleaning methods.
- People risk: Gowning, traffic, and technique consistency are often dominant contamination sources. Training, supervision, and standardized work matter as much as facility design.
- Compliance scope: Confirm whether USP <797> (sterile compounding) and USP <800> (hazardous drugs) apply, then align controls, documentation, and monitoring expectations accordingly.
Controls that must work together
- Airflow and filtration: HEPA alone is not enough. Qualification plus ongoing verification are what make filtration defensible. Recovery performance and operational behaviors materially affect outcomes.
- Flow discipline: One-way personnel and material flows minimize crossovers and eliminate rework loops that amplify contamination opportunities.
- Surface control: Cleaning and disinfection is a method, not a product. Outcomes depend on validated chemistry, correct application, coverage, and technique — not labels alone.
- Evidence of control: Certification, monitoring, trending, and documented response to excursions are the backbone of sustained performance and audit confidence.
Wiping technique: the highest-impact details
Wiping is the fastest way to improve surface outcomes because it is both a cleaning action (soil removal) and a contamination-control action (preventing redeposit). The steps below are written as operator-ready guidance you can adapt to your internal procedures.
Cleanroom wiping guide (step-by-step)
- Follow site protocol (safety, contamination controls) and wear appropriate cleanroom gloves.
- Fold in mid-air into quarter folds to create multiple clean faces and improve contact with the surface.
- Hold the wiper with the folded edge facing the wipe direction; keep unfolded edges in hand to avoid dragging loose edges across the surface.
- Use a pre-wetted wiper or moisten a dry wiper with the appropriate agent.
- Wipe in one direction using straight, parallel strokes, overlapping the previous stroke by 10% to 25%.
- Work clean-to-dirty and typically top-to-bottom, far-to-near, keeping track of completed areas.
- Control wipe faces: use the cleanest face first; change faces frequently; never re-wipe with a used face.
- Dispose of used wipers per site procedure.
Wet spill note: Identify the liquid and follow SDS/MSDS. Choose wipers and gloves compatible with the chemical. For hazardous spills, consider double-gloving and keep outer gloves as dry as practical. Use dry wipers to absorb immediately, then return to the standard wiping steps for final cleaning.
Technique that converts “the right substrate” into real control
- Low-linting materials: Select wipers based on shedding, extractables, and surface compatibility to avoid introducing particles or residues and to protect sensitive finishes.
- Fold discipline: Manage wipe faces intentionally to prevent re-deposit. Change faces frequently rather than spreading soil across a larger area.
- Pattern: Use clean-to-dirty and top-to-bottom patterns to prevent cross-contamination. Avoid “scrubbing circles” unless your SOP explicitly defines it for a verified soil.
- Contact time: If the surface dries early, the disinfection claim may not be achieved. Train for “wet for full dwell time” using the right volume and a defined re-wet rule.
Important nuance: No wiper is truly “lint free.” In cleanrooms, the practical standard is low-linting with controlled particles, fibers, ions, and residues.
Wiper selection: substrate, edge, cleanliness, and format
Selection is driven by substrate + edge treatment + cleanliness/traceability + format (dry vs. pre-wetted; sterile vs. non-sterile). A reliable selection process reduces variability and makes excursions easier to investigate.
Cleanroom wipers: the core “types” that matter in practice
1) Polyester wipers (knit or similar synthetics)
Polyester is often selected for low-linting behavior, solvent tolerance, and strength. Edge treatment matters: sealed-edge/sealed-border options are typically selected when edge-shed control is critical; cut-edge options can be appropriate for less critical zones when supported by cleanliness data.
Polyester is often selected for low-linting behavior, solvent tolerance, and strength. Edge treatment matters: sealed-edge/sealed-border options are typically selected when edge-shed control is critical; cut-edge options can be appropriate for less critical zones when supported by cleanliness data.
2) Microfiber/microdenier wipers
These are commonly used on scratch-sensitive surfaces (e.g., optics, polished metals, coated substrates) and for removing disinfectant residues when a softer, non-abrasive wipe is needed.
These are commonly used on scratch-sensitive surfaces (e.g., optics, polished metals, coated substrates) and for removing disinfectant residues when a softer, non-abrasive wipe is needed.
3) Nonwoven blends (cellulose/polyester “workhorse” wipes)
Blends can balance absorbency (cellulose) with strength and lower particle release (polyester). They are often selected for general cleaning and spill pickup in lower-risk zones.
Blends can balance absorbency (cellulose) with strength and lower particle release (polyester). They are often selected for general cleaning and spill pickup in lower-risk zones.
4) Polypropylene wipers
Polypropylene substrates are frequently used in controlled cleaning and can be paired with alcohol or other solutions in pre-wetted formats.
Polypropylene substrates are frequently used in controlled cleaning and can be paired with alcohol or other solutions in pre-wetted formats.
5) Format drives operator behavior
Pre-wetted formats standardize delivery volume and reduce “over-spray” variability. Sterile formats reduce introduction risk in ISO-classified and sterile workflows.
Pre-wetted formats standardize delivery volume and reduce “over-spray” variability. Sterile formats reduce introduction risk in ISO-classified and sterile workflows.
Texwipe examples customers often map to real-world zones
The wiper cleanliness chart data highlights how different families trend across particles, fibers, non-volatile residue (NVR), ions, and absorbency. Use this as an evidence-based way to match a wiper to a zone.
- Higher-criticality zones (example: ISO Class 3–5): sealed-border families such as Vectra®-processed Alpha® 10 / AlphaSorb® 10 / Quantex™ and sealed-edge options such as ThermaSeal™ are positioned for tighter cleanliness control.
- General cleanroom zones (example: ISO Class 5–8): cut-edge polyester (AlphaWipe®) and other tested options can be appropriate when supported by cleanliness requirements and risk profile.
Selection principle: don’t buy “a wiper.” Buy a measurable cleanliness profile that matches your surface risk, solvent chemistry, and documentation needs.
Pre-wetted wipers: when standardization matters most
Pre-wetted formats are typically chosen to improve repeatability: consistent wetting, fewer variables in application, and easier training. The Texwipe pre-wetted selection guide provides examples across solutions, dispensers, and ISO class fit.
Example product codes (from the selection guide): TX1034, TX1036, TX1039, TX1041, TX1045, TX1048, TX1051 (various sizes/counts); and higher-criticality options (examples) TX1057, TX1082, TX1084, TX1086, TX1088; plus additional listings such as TX8385, TX8398, TX8410, TX8415, TX8442, TX8488.
Field note: sealed-border Vectra® processing is positioned to reduce “oligomer blooming” sometimes observed with high-alcohol pre-wetted use on certain substrates.
Cleanroom-grade alcohol: why sterile, controlled alcohol is the standard
Risk statement: In ISO-classified and sterile compounding environments, alcohol is not “just alcohol.” The risk is that an uncontrolled solvent and delivery method can introduce particles, residues, variability, and documentation gaps that undermine contamination control and compromise investigation defensibility.
Why alcohol is used in cleanrooms
Alcohol is widely used because it is fast-acting against many vegetative organisms and can leave minimal residue when properly specified and applied. In sterile compounding workflows, sterile 70% alcohol is commonly used as a routine disinfectant for ISO-classified surfaces, including within primary engineering controls (PECs), when applied with disciplined technique.
Why normal/general-purpose alcohol does not belong in cleanrooms
- Sterility and ISO-surface fit: General-purpose alcohol is not sterile and is not packaged for ISO-critical handling, creating an avoidable contamination pathway.
- Particles and packaging risks: Consumer bottles, pump tops, and triggers can shed particles and become contamination reservoirs at nozzle interfaces.
- Residue and impurity risk: Denatured alcohols and lower-grade solvents may include denaturants/impurities that can leave non-volatile residues or films.
- Water-quality variability: “70%” performance depends on the water used; uncontrolled water can introduce ions, residues, or microbial burden.
- Documentation gaps: Missing lot traceability, expiry, and quality documentation complicates deviation investigations and root-cause analysis.
Best-practice alcohol use (operator-ready)
- PEC rule: Do not spray in the hood. Apply alcohol using sterile, low-linting wipes/applicators to control aerosols and overspray while ensuring consistent coverage.
- Sequence: Clean first (soil removal), then disinfect. Alcohol is commonly a routine step — not a substitute for cleaning when soils are present.
- Drying: Allow surfaces to fully dry before initiating or resuming critical work to support intended effectiveness and reduce recontamination risk from pooling or wet contact.
Sporicidal disinfectants: specific uses, where they fit, and when they are needed
Risk statement: If a contamination-control program relies only on non-sporicidal disinfectants, bacterial spores and other highly resistant environmental forms can persist on surfaces, seed recurring contamination, and drive long-cycle “resident flora” problems that routine chemistries may not reliably eliminate.
What sporicidal disinfectants do — and why they matter
Sporicidal disinfectants are designed to inactivate bacterial spores and other resistant forms that can survive routine disinfection. Spores can persist for extended periods, particularly in seams, corners, and residue-prone areas, and can repeatedly reintroduce contamination if the program never includes a sporicidal “reset.”
How sporicides fit into a layered program
- Clean: Remove soils/residues so chemistry can contact the surface.
- Routine disinfect: Daily/shift control for vegetative organisms.
- Sterile alcohol (as applicable): Fast, routine surface disinfection for ISO/PEC workflows; not sporicidal.
- Periodic + event-driven sporicide: Reduces spore burden, prevents long-cycle “resident” contamination, and provides a deliberate reset mechanism.
When sporicide is needed (routine and event-driven triggers)
- Routine cadence: Define a minimum schedule for classified areas — commonly monthly or risk-based by zone (higher-risk zones more frequent).
- After viable excursions: Adverse trends, repeated mold recoveries, recurring Bacillus, or “resident flora” signals.
- After disruptive events: Maintenance intrusions, construction, HVAC upset, water leaks, drain backups, ceiling disturbance, power outages.
- After procedural breakdowns: Gowning breaches, uncontrolled traffic, improper material introduction, spill events that spread beyond the initial footprint.
Technique that makes sporicides work (and prevents damage)
- Pre-clean first: Sporicides do not reliably “cut through” heavy films; remove soils so sporicide contacts the surface uniformly.
- Control wet contact time: “Wet for full dwell time” must be explicit, including re-wet rules and how to handle early drying.
- Prefer wipe application in critical zones: Controlled wiping reduces aerosolization and turbulence in PEC contexts.
- Residue management: Many sporicides leave films. Define when sterile water and/or sterile alcohol follow-up is required after contact time.
- Compatibility and safety: Specify do-not-use surfaces, PPE requirements, ventilation notes, and spill response to avoid corrosion, degradation, and exposure.
Mopping technique: walls and floors without recontamination
Floors and lower walls are where contamination accumulates and where recontamination is easiest. The mopping method below is designed to reduce “track-back,” control mop media, and preserve clean-to-dirty flow.
Mopping guide (step-by-step)
- Use a pre-wetted mop cover or wet a dry cover with the appropriate agent.
- Slip the mop cover onto the mop head.
- Walls: clean top-down, clean-to-dirty, dry-to-wet; use linear overlapping strokes; change mop cover every 25 wall “steps” (one mop width top-to-bottom) or more frequently if heavily soiled.
- Floors: clean in small rectangular sections; use linear overlapping strokes; mop doorways/high-traffic areas last; change mop cover after ~100 sq ft (9.3 m²) or more frequently if heavily soiled.
- Damp mopping is more effective than dry mopping for contamination removal.
- Bag used mop covers per site procedure.
Product mapping (examples): Texwipe AlphaMop™ systems are commonly used to support standardized technique with compatible handles, heads, and covers in controlled environments.
Isolator cleaning: controlled entry, systematic wiping, corner work
Isolators and pass-throughs are high-control spaces that can still fail from poor entry discipline or inconsistent stroke patterns. The guide below emphasizes equilibrium time, sequence, and controlled tooling.
Isolator cleaning guide (step-by-step)
Preparation for cleaning
- Wipe down gloved hands and cleaning products with wipers pre-wetted with 70% IPA, then place items in the pass-through.
- Close the pass-through and wait the prescribed time for the pass-through to reach equilibrium.
- Wipe gloved hands with 70% IPA, then place hands into the isolator gloves.
- Open interior pass-through door, bring components into isolator interior, close door, and wait the prescribed time for the isolator to reach equilibrium.
Cleaning the isolator
- For surfaces not within arm’s reach, use a cleaning tool with a mop cover moistened with IPA.
- For surfaces within reach, use a quarter-folded wiper wetted with IPA (or a pre-wetted wiper).
- Sequence: begin with top surface (“ceiling”) carefully to avoid filter damage, then back wall, side walls, and finish with the deck.
- Work high-to-low, clean-to-dirty, dry-to-wet.
- Use straight, parallel, overlapping strokes; change wiper surfaces each stroke and mop covers as needed.
- Use IPA-moistened swabs for corners and tight areas.
- Dispose of used wipers, swabs, and mop covers per procedure (bag or disposal port).
Corner and interface work: where outcomes are won
Corners, seams, gaskets, and door interfaces are where residue films and viable contamination can persist. Swabs are not “nice-to-have” here — they are how you make the cleaning method real at the micro-scale. Use solvent-compatible heads and controlled application (moistened, not dripping) for repeatable recovery and lower redeposit.
Swab sampling: cleaning validation and residue recovery basics
Swab sampling is how many teams connect “we cleaned it” to measurable evidence — whether that evidence is TOC, HPLC, or other analytical endpoints. It is especially valuable on irregular surfaces, hard-to-reach areas, and places where product or cleaning residue can hide.
Swab requirements (what “good” looks like)
- Minimal background interference (low residues/low extractables for the test method)
- High recovery rate (method and substrate support effective pickup)
- Low particle generation (especially when sampling sensitive equipment or surfaces)
Swab sampling procedure (operator-ready)
- Select an appropriate swab for the surface geometry and analytical method.
- Define the area to be tested (template, dimensions, or marked region).
- Dampen the swab with the specified diluent (controlled wetting improves recovery and reduces friction-induced shedding).
- Swab with an overlapping pattern, then flip the swab and repeat in a perpendicular direction.
- Repeat with a second swab at 45° angles, and swab the perimeter for a complete capture method.
- Keep the entire head flat against the surface during sampling to maintain contact consistency.
- Transfer the swab head to the vial per method (some designs use a notch for snap-off transfer).
Texwipe examples referenced in the swab sampling guide: TX714K (Low TOC Alpha® Swab), TX761K, TX715, TX716, and TOC Cleaning Validation Kits such as TX3340 and TX3342 (kit packaging designed to support controlled transport and reduced contamination risk).
Compatibility charts: avoiding degraded materials and hidden residues
Compatibility is not an academic topic. Material degradation creates particles, residues, and variability — and can turn a “cleaning” event into a contamination event. Use compatibility charts as a pre-job control, not an after-the-fact explanation.
Swab solvent compatibility (head + handle)
The swab solvent compatibility chart compares how common swab head substrates (foam, polyester, polypropylene) and handle materials respond to solvents: U = Unaffected, S = Swells, D = Degrades (at room temperature). Use it to prevent swelling/degradation when sampling with solvents such as acetone, MEK, acids, or alcohols.
Wiper chemical compatibility (substrate fit)
The wiper chemical compatibility chart maps common chemistries (acids, alcohols, bases, solvents) against wiper substrates (nylon, polyester, polyester/cellulose, polypropylene, blends). Use it before you standardize a disinfectant rotation or assign a solvent wipe step.
SOP suggestions: standard and advanced building blocks
SOSCleanroom does not author your SOPs. What we can provide is a practical framework you can adapt, validate, and approve through your quality unit and local regulatory expectations. Use the blocks below as a starting point to standardize training and reduce operator-to-operator variability.
Standard SOP building blocks (baseline)
- Daily/shift wipe-down: defined sequence (high-to-low), defined chemistry, quarter-fold method, overlap requirement, wipe-face change rule, defined dwell time behavior.
- Floor mopping: defined room zoning, rectangular sections, doorway-last rule, mop cover change triggers (area-based), and disposal method.
- Isolator/pass-through cleaning: entry wipe-down with 70% IPA, equilibrium wait time, ceiling-to-deck sequence, corner swab step, disposal route.
- Spill response: identify material, PPE/glove compatibility, immediate dry pickup, then standardized wipe-down and disposal.
- Training & qualification: initial training, periodic reassessment, and documented observation criteria (folding, stroke discipline, dwell time, and flow control).
Advanced SOP building blocks (audit-defensible)
- Disinfectant rotation strategy: routine disinfect + event-driven sporicide + residue management step (sterile water/sterile alcohol as applicable) with compatibility limits.
- Dwell-time execution: “wet for full dwell time” defined by zone, including re-wet rules, acceptable early-dry responses, and documentation expectations.
- Material introduction controls: wipe-down steps for supplies entering controlled spaces, with packaging removal strategy and defined staging zones.
- Swab sampling/validation method: defined sample area templates, dampening rules, stroke patterns, transfer to vial rules, and chain-of-custody expectations.
- Trending and escalation: what constitutes an excursion, who is notified, what is re-cleaned, how retraining is triggered, and what is documented.
Compliance context: ISO 14644, USP <797>, USP <800>, and audit defensibility
Compliance is not only “having a cleanroom.” It is proving control through classification, qualification, monitoring, and documented response. The details vary by industry and regulator, but the same logic applies: cleanrooms are designed to reduce contamination risk, and your documentation must show that your controls work in practice.
ISO 14644 (cleanroom classification and monitoring)
ISO 14644-1 and ISO 14644-2 are widely used global standards for cleanroom classification and ongoing monitoring of air cleanliness by particle concentration. Practical takeaway: “ISO class” is not just a design label — it is an expectation you verify, trend, and maintain through behaviors and maintenance discipline.
USP <797> (sterile compounding) — what it forces you to get right
- Personnel training and evaluation: aseptic technique and ongoing competency are fundamental requirements.
- Facilities and engineering controls: ISO-classified environments, PECs, and controls that support sterile compounding workflows.
- Environmental monitoring and cleaning: documented cleaning/disinfection processes and evidence of sustained control.
- Documentation and defensibility: training records, cleaning logs, monitoring trends, and response to excursions.
Note: USP chapters are standards; enforcement and timelines are set by state boards and regulators. Align your program with your applicable authority.
USP <800> (hazardous drugs) — exposure control and containment
USP <800> focuses on safe handling of hazardous drugs to minimize exposure risk to personnel, patients, and the environment. Practical takeaway: cleaning is not only about microbial control — it is also about hazardous residue removal and containment.
- Engineering controls: containment primary and secondary controls (C-PEC, C-SEC) and supplemental controls (e.g., closed-system transfer devices) as applicable.
- Assessment of risk: how dosage forms and handling steps affect required controls.
- Cleaning expectations: defined, documented steps to reduce hazardous residue in areas where contamination can occur.
- Reference lists: NIOSH hazardous drug lists are commonly used as an input to risk determinations.
Global sterile manufacturing references (where applicable)
If you manufacture sterile products beyond compounding, additional guidance documents may apply based on jurisdiction (example: EU GMP Annex 1; FDA aseptic processing guidance). Even when not strictly required for your site, these references can be useful for building a risk-based program and strengthening your “evidence of control.”
What we see and have learned from our customers
The most common root causes behind “mystery” contamination events are simple, correctable behaviors — and they show up in audits, investigations, and trends. Here are patterns we see repeatedly, and what typically fixes them.
- Problem: “We disinfected, but results don’t improve.”
Fix: Separate cleaning (soil removal) from disinfection, standardize dwell time, and define re-wet rules so contact time is achieved in practice. - Problem: “We used the right chemistry, but residues appear.”
Fix: Choose higher-purity chemistry, validate residue management steps, and match wiper substrate to solvent/chemical compatibility. - Problem: “Training drift” (same SOP, different outcomes).
Fix: Train to observable behaviors: quarter-fold, one-direction strokes, 10–25% overlap, face-change rules, and defined sequence. - Problem: Corners and seams fail repeatedly.
Fix: Make swabbing a required corner/interface step, with solvent compatibility checks and controlled wetting. - Problem: Supply substitutions cause variability.
Fix: Lock critical consumables (wipers, swabs, gloves, alcohol formats) and use a partner that prioritizes continuity of supply and documented product consistency.
How SOSCleanroom supports your program
- Consumables you can standardize: low-linting wipers, cleanroom swabs, controlled alcohol formats, disinfectants and sporicides, mopping systems, gloves, and garments.
- Fast shipping and continuity: fewer last-minute substitutions and fewer “workarounds” that create risk.
- Customer service that works like a partner: selection help, cross-compatibility thinking, and practical support for keeping your program stable.
- Experience you can lean on: 40+ years supporting controlled environments with multi-award-winning reliability.
Source basis
SOSCleanroom training materials and charts
- SOSCleanroom — Training Material and How-To Guides page (isolator, mopping, swab sampling, wiping, compatibility, cleanliness and selection charts).
- Cleanroom Wiping Guide (Texwipe poster): quarter-fold method, one-direction strokes, 10–25% overlap, clean-to-dirty sequencing.
- AlphaMop™ Mopping Guide (Texwipe poster): wall and floor method, cover change triggers (25 steps / 100 sq ft), doorway-last logic.
- Isolator Cleaning Guide (Texwipe poster): controlled entry, equilibrium wait, ceiling-to-deck sequence, corner swabbing.
- Swab Sampling Proper Procedure (Texwipe poster): multi-direction sampling pattern, transfer method, TOC/HPLC context and example product codes (TX714K, TX761K, TX715, TX716, TX3340, TX3342).
- Swabs Solvent Compatibility chart (Texwipe): U/S/D compatibility at room temperature for common solvents.
- Wiper Chemical Compatibility chart (Texwipe): chemical classes vs. substrate compatibility (acids/alcohols/bases/solvents).
- Wiper Cleanliness Chart (Texwipe): relative particles/fibers, NVR, ions, and absorbency across wiper families; includes a note on ASTM E2090 sensitivity.
- Pre-wetted Wiper Selection Guide (Texwipe): example product codes, formats, solutions, and substrate positioning.
Institutional and standards references (added for context)
- USP — General Chapter <797> (sterile compounding): scope includes responsibilities, training, facilities, environmental monitoring, and storage/testing.
- USP–NF Publication Announcement: Revised <797> published Nov. 1, 2022, official Nov. 1, 2023 (one-year implementation period).
- USP — General Chapter <800> (hazardous drugs): standards for safe handling to minimize exposure risk; implementation resources and FAQs.
- CDC/NIOSH — List of Hazardous Drugs in Healthcare Settings (most recent list used as an input to HD identification and risk decisions).
- ISO — ISO 14644-1 and ISO 14644-2 overview (classification and monitoring of air cleanliness by particle concentration).
- European Commission — EU GMP Annex 1 (Manufacture of Sterile Medicinal Products), 2022 revision (QRM emphasis for microbial/particulate/endotoxin control).
- FDA — Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice (Guidance for Industry).
- IEST — Recommended Practice on evaluating wiping materials used in cleanrooms (IEST-RP-CC004 series).
Editorial note: This guide is educational and should be adapted, validated, and approved under your site’s quality system and applicable regulatory authority.