Roller Compactor Cleaning Validation Protocol and Acceptance Criteria

Comprehensive Roller Compactor Cleaning Validation Protocol and Acceptance Criteria

Comprehensive Roller Compactor Cleaning Validation Protocol for Oral Solid Dosage Manufacturing

Purpose and Scope

This document establishes the foundation for the cleaning validation protocol and standardized cleaning procedures specifically designed for roller compactors used in the manufacturing of oral solid dosage forms. The main objective is to ensure that all residues of active pharmaceutical ingredients (APIs), excipients, cleaning agents, and potential microbial contaminants are effectively removed within predetermined limits, mitigating cross-contamination risks and adhering to current Good Manufacturing Practices (cGMP) and regulatory guidelines.

This protocol covers cleaning validation strategy, equipment and component overview, cleanability considerations, and initial preparatory elements leading towards acceptance criteria and sampling methodology defined in subsequent parts. It applies to all roller compactor units utilized in product manufacturing processes where cross-contamination control is critical.

Definitions and Abbreviations

Term Definition
API Active Pharmaceutical Ingredient
Cleaning Validation Documented process that proves the effectiveness and consistency of residue removal from equipment surfaces
CQA Critical Quality Attribute
cGMP Current Good Manufacturing Practices
MACO Maximum Allowable Carryover; highest acceptable quantity of residue from prior product that may remain on equipment without risk of contamination
PDE/ADE Permitted Daily Exposure/Acceptable Daily Exposure; toxicological limits used to calculate MACO values
Rinse Volume The volume of solvent or water used to rinse equipment surfaces during cleaning
Swab Area Surface area from which residue samples are collected via swabbing
SOP Standard Operating Procedure
TOC Total Organic Carbon; measure of organic residues used as an indicator for detergent or product residues

Responsibilities

Role Responsibilities
Quality Assurance (QA) Approval of cleaning validation protocol and acceptance criteria, review of validation reports, ensuring compliance
Quality Control (QC) Execution of analytical testing of samples (swabs, rinses), documentation of results
Validation Team Development and maintenance of cleaning validation protocols, execution of validation runs, data analysis and reporting
Production Implementation of cleaning procedures, equipment operation, recording cleaning execution and deviations
Engineering Maintenance and calibration of cleaning and sampling equipment, support in cleaning procedure optimization
Safety Officer Ensuring appropriate PPE and safety protocols during cleaning and sampling processes

Safety and Personal Protective Equipment (PPE)

All personnel involved in the cleaning and validation processes must adhere to site-specific safety guidelines. Proper PPE is mandatory to prevent exposure to residual APIs, cleaning agents, and potential contaminants. Minimum PPE requirements include:

  1. Protective gloves (chemical-resistant gloves suitable for detergents used)
  2. Disposable coveralls or gowns
  3. Hairnets and beard covers
  4. Safety goggles or face shield
  5. Respiratory protection if required based on risk assessment (dust masks or respirators)

Personnel must receive training on handling cleaning agents and residue sampling techniques to ensure safety and data integrity.

Equipment Overview and Product-Contact Parts

The roller compactor is a critical unit operation used for dry granulation in the production of oral solid dosage forms. Understanding the geometry, materials of construction, and interfaces in contact with product or cleaning agents is essential for effective cleaning validation design.

Equipment Component Description and Material of Construction Product Contact
Feed Hopper Stainless steel 316L, polished surface finish Yes
Compaction Rolls Chrome-plated steel, smooth rolled surface Yes
Roller Gap Adjustment Mechanism Steel with non-contact surfaces No
Product Discharge Chute Stainless steel 316L, welded construction Yes
Granules Collection Area Stainless steel trays with removable liners Yes
Drive Mechanism Housing Enclosed non-contact parts No
Seals and Gaskets FDA-approved elastomers, CIP compatible Interface with product

Cleaning Strategy Overview

The cleaning approach for the roller compactor focuses on effectively removing residual APIs, excipients, and cleaning agents from all product-contact surfaces to prevent cross-contamination and ensure product quality. The strategy includes:

  • Dry Cleaning: Initial removal of bulk product residues by brushing, vacuuming, or compressed air, minimizing dust generation.
  • Wet Cleaning: Use of validated detergent formulations to dislodge API and excipient residues from surfaces.
  • Rinsing: Multiple rinses with purified water to remove detergent residues and loosened product matter.
  • Verification Sampling: Execution of defined swabbing and rinse sampling to confirm removal efficacy.
  • Hold Time Considerations: Defined maximum hold times between production and cleaning to avoid residue adherence or microbial proliferation.

Periodic review and optimization of cleaning procedures based on process improvements and product changes are integral to the cleaning strategy.

Cleaning Agents and Tools List

Agent/Tool Description Purpose
[detergent_name] Pharmaceutical-grade detergent with defined pH and compatibility Removal of API/excipient residues
Purified Water Water for Injection (WFI) or Pharmaceutical Grade Water Rinsing of equipment post-detergent application
Lint-free Swabs Swabs meeting USP physical and chemical cleanability standards Sampling of defined surface areas
Brushes Non-abrasive brushes compatible with stainless steel Dislodging dried residues
Vacuum Cleaner with HEPA Filter Industrial vacuum system with high-efficiency filters Dry cleaning residue removal
Personal Protective Equipment (PPE) As specified in Safety section Protection of personnel

Hold Time Definitions

Condition Maximum Hold Time Rationale
Dirty Hold Time [dirty_hold_time_hours] Max duration between end of production and start of cleaning to prevent residue hardening and microbial growth
Clean Hold Time [clean_hold_time_hours] Max duration for cleaned equipment before use without re-cleaning
Sampling Window [sampling_time_window_hours] Permissible timeframe for validation sampling post-cleaning

Records and Forms List

  • Cleaning Procedure Log Sheet
  • Cleaning Validation Protocol Document
  • Swab and Rinse Sample Collection Forms
  • Analytical Testing Reports (TOC, API residual assay, detergent residue assay)
  • Non-Conformance and Deviation Reports
  • Personnel Training Records
  • Equipment Maintenance and Calibration Certificates
  • Cleaning Acceptance Criteria Calculation Worksheets

Site-specific Inputs Required

  • Name and concentration of the detergent used ([detergent_name])
  • Rinse volume per cleaning step ([rinse_volume_L])
  • Surface area for swab sampling per location ([swab_area_cm2])
  • Hold time limits for dirty and clean conditions ([dirty_hold_time_hours], [clean_hold_time_hours])
  • Preferred analytical methods for residue and detergent determination (e.g., TOC, HPLC method references)
  • Maximum dosage strengths of products processed on the roller compactor
  • Risk-based decision on microbial limits application
  • Specific PPE policies and safety requirements
  • Identification of all product-contact surfaces and corresponding surface area measurements
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Equipment Description and Component Breakdown

The roller compactor is a critical piece of equipment utilized for dry granulation in oral solid dosage manufacturing. Understanding its construction and individual components is essential for developing an effective cleaning validation protocol and cleaning procedure.

Component Description Cleaning Challenges
Feed Hopper Initial feeding point for powders into the compactor rollers. Powder residues and fines may accumulate; accessible for swabbing but shape complexity may hinder cleaning.
Compaction Rollers Two counter-rotating rollers that compress powders into ribbons. Critical for API removal validation; tight roller gaps and roller surface texture complicate cleaning.
Scraper Blades Remove compacted ribbons from rollers. Contact with product ribbons can leave residues; disassembly may be necessary for thorough cleaning.
Discharge Chute Guides the compacted ribbons to downstream equipment. Contact area where fines settle; moderate cleaning difficulty due to chute slope and corners.
Drive Motor and Drive Shaft Mechanical components for powering rollers. Not product-contacting; routine external cleaning recommended.
Frame and Support Structures Equipment support without direct product contact. General hygiene cleaning recommended; not included in residue validation.

Materials of Construction and Surface Finish

The roller compactor surfaces in direct contact with product are generally constructed from stainless steel (316L), finished to a surface roughness of Ra ≤ 0.8 µm to minimize residue adherence and facilitate cleaning. Welds and joints are hygienically designed to prevent dead legs and accumulation sites. Critical surfaces should be visually inspected and Holistically maintained to ensure integrity of the finish.

Risk Assessment and Critical Quality Attributes (CQAs) for Cleaning Validation

A systematic risk assessment guides the selection of critical surfaces for cleaning validation and the definition of acceptance criteria.

  • Residue Risks: APIs with low PDE/ADE values, high potency compounds, detergents, and microbiological contamination risks.
  • Cleaning Difficulty: Surface complexity, equipment accessibility for disassembly, and historic knowledge of product/excipient adhesion.
  • CQAs: Residual API level, total organic carbon (TOC) levels for detergents, visible cleanliness, and microbiological levels (where applicable and risk-assessed).

Cleaning Validation Strategy

The protocol employs a science- and risk-based approach combining toxicological evaluation with analytical testing to meet regulatory expectations.

  • Approach: Use PDE/ADE values for APIs to calculate MACO limits as the primary acceptance criteria.
  • Cleaning Methods: Validated cleaning procedures including manual cleaning, automated CIP (if applicable), and optimized rinsing cycles.
  • Sampling Techniques: Swab sampling at predefined critical surfaces, rinse sampling for residual detergent verification, and visual inspection.
  • Analytical Methods: Sensitive and validated methods including HPLC for API residues, TOC for detergent residues, and microbiological testing when justified.
  • Validation Runs: Conduct minimum of three consecutive successful cleaning cycles under worst-case scenarios.

Pre-Validation Preparation

  1. Ensure detailed documentation of prior product manufactured, including batch size and API potency.
  2. Conduct equipment inspection and verification of materials, surface finishes, and component integrity.
  3. Develop a comprehensive cleaning procedure with input from production, engineering, and quality teams.
  4. Train relevant personnel on cleaning execution, documentation, and sampling methods prior to validation runs.
  5. Define the worst-case residue scenario based on product characteristics and operational parameters.
  6. Prepare sampling kits, validated analytical methods, and cleaning verification forms.

Site-Specific Inputs Required

  • List of products processed prior to cleaning validation (API potency, batch size)
  • [detergent_name] used and compatible analytical detection method
  • Rinse volumes [rinse_volume_L] and number of rinse cycles
  • Defined swab sampling areas [swab_area_cm2] and critical sampling locations
  • Details of cleaning equipment and cleaning process parameters
  • Microbial acceptance criteria if applicable based on risk assessment

Roller Compactor Cleaning Validation Protocol and Acceptance Criteria

Cleaning Procedure for Roller Compactor

  1. Pre-Cleaning Preparation
    1. Ensure the roller compactor is powered off and locked out/tagged out according to site safety procedures.
    2. Remove bulk product residues by scraping and vacuuming from accessible surfaces including rollers, feeders, and collection bins.
    3. Document initial visible soil levels with photographic evidence before cleaning.
  2. Disassembly
    1. Disassemble all removable parts that come in direct contact with the product including rollers, feed hoppers, chute plates, and associated seals and gaskets.
    2. Place disassembled parts on a sanitized and clean workbench designated for cleaning activities.
    3. Record parts removed in the cleaning log with time and personnel involved.
  3. Washing
    1. Prepare a cleaning solution using the approved detergent ([detergent_name]) at the specified concentration following manufacturer instructions and site-specific SOP.
    2. Manual wash or soak parts depending on size and accessibility using brushes or cloths ensuring all surfaces, crevices, and corners are cleaned thoroughly.
    3. Use automated cleaning systems if available and validated for this equipment.
    4. Change detergent solution whenever visibly soiled or according to site SOP to prevent redeposition.
  4. Rinsing
    1. Rinse all cleaned surfaces and parts thoroughly with purified water or water for injection depending on site specifications and product risk profile.
    2. Use a minimum of [rinse_volume_L] liters per rinse cycle or until no detergent residue is detectable by onsite verification methods (TOC, conductivity).
    3. Multiple rinses may be performed to ensure complete removal of detergent residues.
  5. Drying
    1. Dry parts using filtered compressed air or clean lint-free towels depending on the part and site SOP.
    2. Ensure that all drying agents used are compatible with product and cleaning residue testing.
    3. Allow parts to air dry in a controlled environment if necessary to meet humidity and particulate requirements.
  6. Reassembly
    1. Reassemble all parts according to manufacturer’s specifications and site assembly instructions.
    2. Verify correct fit and alignment of rollers, seals, and feeding mechanisms.
    3. Record reassembly completion time and personnel involved in the cleaning log.
  7. Visual Inspection
    1. Conduct a detailed visual inspection of the fully reassembled roller compactor focusing on product contact surfaces, seams, and hard-to-clean areas.
    2. Utilize adequate lighting and magnification where necessary.
    3. Record inspection results and capture photographic evidence if any residue or doubtful cleanliness is noted.
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Cleaning Parameters and Acceptance Monitoring

Cleaning Step Parameter Target Value / Range Monitoring Method Frequency Site-Specific Inputs Required
Pre-cleaning Removal of bulk product Visual confirmation of no visible product residues Visual inspection Every cleaning None
Disassembly Complete removal of product contact parts 100% removal confirmed Check against parts list Each cleaning cycle Equipment parts list
Washing Detergent concentration Specified by detergent manufacturer (e.g. 0.5% w/v) Prepared solution verification by titration or conductivity Each cleaning cycle [detergent_name], concentration range
Rinsing Rinse volume and quality Minimum [rinse_volume_L] liters, conductivity < site limit Water conductivity meter, TOC analyzer if applicable Each rinse [rinse_volume_L], conductivity limits
Drying Residual moisture level Dry to visibly dry, moisture monitoring if applicable Visual, moisture meters if validated Post drying Equipment humidity guidelines
Visual Inspection Residue absence No visible residues, discoloration, or corrosion Visual and photographic documentation Each cleaning Lighting conditions

Sampling Plan for Cleaning Validation

Sampling Location Rationale for Location Sampling Method Swab Area (cm²) Number of Swabs Per Location Sample Labeling and Chain-of-Custody Sample Handling and Transportation
Roller Surface Primary product contact area with potential residue retention Surface Swabbing [swab_area_cm2] 2 swabs (front and back roller) Label with equipment ID, sampling date/time, sample ID, sampler initials; use tamper-evident seals Transport in cooled containers to QC lab within [time_hours]; store as per analyte stability
Feed Hopper Interior High product contact, holds product prior to compaction Surface Swabbing [swab_area_cm2] 2 swabs Label as above As above
Chute and Discharge Plate Potential for product residue accumulation post-compaction Surface Swabbing [swab_area_cm2] 2 swabs Label as above As above
Seals and Gaskets on Rollers Small crevices prone to residual entrapment Surface Swabbing or Rinse Sampling [swab_area_cm2] 2 swabs Label as above As above
Rinse Water Samples (Post Final Rinse) Verify absence of detergent and product residues after final rinse Collect rinse water sample (minimum 100 mL) N/A 1 sample per cleaning cycle Label with rinse cycle number, date/time, sampler initials; sealed container Immediate transport to lab under controlled conditions

Sampling Procedure Details

  1. Surface Swabbing
    1. Use pre-moistened sterile swabs with appropriate solvent (e.g. purified water or validation-specified solvent).
    2. Swab the defined area ([swab_area_cm2]) by wiping horizontally, vertically, and diagonally to maximize coverage.
    3. Place swab into labeled sterile container immediately after collection and seal.
  2. Rinse Sampling
    1. Collect rinse solution at the end of the final rinse step in a sterile, labeled container.
    2. Avoid external contamination by wearing gloves and using aseptic technique.
    3. Seal and store sample as per handling guidelines.
  3. Sample Labeling
    1. Each sample must include equipment ID, sampling location, date and time, sampler’s initials, and unique sample code according to site coding system.
    2. Use tamper-evident materials for sealing sample containers.
  4. Chain-of-Custody
    1. Record sample collection details, time, and personnel on chain-of-custody forms.
    2. Transfer samples under controlled conditions to the Quality Control laboratory and document handover details.
  5. Sample Handling and Storage
    1. Store samples at conditions specified based on analyte stability (e.g. 2-8°C for biological or detergent residues).
    2. Analyze samples promptly within validated holding time to ensure data integrity.

Site-Specific Inputs Required

  • [detergent_name] – Approved detergent for cleaning roller compactor parts
  • [rinse_volume_L] – Minimum rinse volume per rinse cycle
  • [swab_area_cm2] – Defined swab area per sampling location
  • Equipment parts list and disassembly instructions
  • Conductivity and TOC limits for rinse water validation
  • Sample stability and storage requirements
  • Lighting and magnification standards for visual inspection
  • Cleaning solution preparation and concentration confirmation method
  • Safety and PPE requirements during cleaning process

Analytical Method Performance: Recovery, LOD, and LOQ Expectations

To ensure that the cleaning validation of the roller compactor is scientifically sound and capable of detecting residues at or below the established acceptable levels, the analytical methods employed must demonstrate appropriate performance characteristics. These include recovery, Limit of Detection (LOD), and Limit of Quantification (LOQ).

  • Recovery: The method should demonstrate recovery rates between 80% and 120% for the active pharmaceutical ingredient (API), degradation products, and cleaning agents from relevant surfaces. Recovery studies must be conducted on representative material surfaces of the roller compactor, such as stainless steel contact points, to simulate actual conditions.
  • LOD and LOQ: The analytical method should have an LOD and LOQ well below the Maximum Allowable Carryover (MACO) limit calculated via the PDE/ADE approach, ensuring reliable detection and quantification of residues. Typically, the LOD should be at least one-third and the LOQ at one-tenth of the MACO value. This margin ensures sensitive and precise residue measurement to unequivocally confirm cleanliness.

Site-specific acceptance thresholds and method validation details should be included in the analytical method validation report. Representative placeholder values might include:

Parameter Expected Value Site-Specific Input Required
Recovery (%) 80–120% No
LOD (mg/cm2) <= [calculated MACO/3] Yes: MACO value, swab surface area
LOQ (mg/cm2) <= [calculated MACO/10] Yes: MACO value, swab surface area

Acceptance Criteria Methodology

The cornerstone of acceptance criteria for roller compactor cleaning validation is the PDE/ADE-based MACO calculation methodology, reflecting current industry best practices for oral solid dosage manufacturing.

PDE/ADE-based MACO Calculation Framework

The MACO (Maximum Allowable Carryover) is calculated using the Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) of the previous product, ensuring patient safety from cross-contamination. This is a risk-based approach that allows for product-specific cleanup limits tailored to toxicity and dosage.

Key parameters required include:

  • PDE/ADE value for the previous product (mg/day) — derived from toxicological data or regulatory guidance.
  • Minimum daily dose of the next product (mg) — used to calculate carryover limits applicable to a patient dose.
  • Batch size or Maximum Daily Dose (MDD) — relevant in some calculations to reflect production scale.
  • Safety factors — typically 1/100 to 1/1000 depending on risk assessment and regulatory expectations.
  • Sampling surface area (cm2) — for residue quantification normalization.
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The general MACO calculation formula is:

Parameter Example Placeholder Value Description
PDE/ADE [PDE_prev_product_mg/day] Permitted daily exposure of prior product
Max daily dose next product [Dose_next_product_mg] Smallest daily dose of new product
Safety factor [Safety_factor] 1/100 to 1/1000 (site specific)
Swab sampling surface area [swab_area_cm2] Contact area of swab
MACO (mg/cm2) MACO = (PDE / Dose_next_product) x Safety_factor / swab_area_cm2 Maximum residue per square cm allowed

The analytical acceptance criteria will then compare the measured residue concentration per surface area to this MACO value. Residues below MACO confirm effective cleaning.

Fallback Legacy Criteria (Informative)

As an industry fallback and where applicable, a legacy acceptance criterion can be referenced: no residue above 10 ppm or 1/1000 of the therapeutic dose of the previous product. These are considered conservative but lack specificity compared to PDE-based approaches and should only be used if toxicological data are unavailable.

Detergent Residue Acceptance and Rationale

Detergent or cleaning agent residues must be assessed and controlled based on their potential impact on product quality, stability, and patient safety. Acceptance limits should be correlated with analytical method capabilities.

Detergent residue rationale includes:

  • Methodology: Total Organic Carbon (TOC) analysis, conductivity testing, or detergent-specific assays (e.g., colorimetric surfactant assays) are generally employed to quantify residual detergent.
  • Acceptance values: Limits established from the validated method’s sensitivity and toxicological data. For example, TOC limits may be set at ≤ [TOC_limit] mg/cm2 calibrated for [detergent_name].
  • Rationale: Residual detergent must not exceed levels that could degrade product integrity or pose safety concerns, including sensitization or toxicity in final dosage forms.
  • Site-specific factors: Detergent type, contact surfaces, rinsing volumes, and equipment design affect residue potential and therefore acceptance criteria.

This approach ensures that all cleaning agents are sufficiently removed or reduced to acceptable safe levels, validated through appropriate analytical methods.

Deviations and Corrective and Preventive Actions (CAPA)

Deviations from the established cleaning validation acceptance criteria or procedure must be addressed promptly to maintain process integrity and regulatory compliance.

Deviation Type Examples Recommended CAPA
Analytical Non-compliance Residue above MACO, method out-of-specification
  1. Investigate residual cause (process, sample handling, method).
  2. Repeat sampling and analysis as per validated procedures.
  3. Review cleaning procedure adequacy.
  4. Implement cleaning process improvements.
  5. Document CAPA and evaluate impact on batch disposition.
Procedure Deviation Incorrect cleaning times, wrong detergent, temperature deviations
  1. Identify root cause.
  2. Retrain operators.
  3. Revise standard operating procedures if necessary.
  4. Increase monitoring frequency.
Equipment or Sampling Deviations Swabbing deviations, equipment contamination
  1. Review and retrain sampling team.
  2. Re-clean and resample according to protocol.

All CAPAs should be documented within the quality system and subject to periodic effectiveness review during ongoing cleaning performance monitoring.

Continued Verification Plan

Cleaning validation is a lifecycle process supported by ongoing verification to ensure sustained cleaning effectiveness throughout commercial manufacturing.

The continued verification plan should include:

  • Periodic re-sampling and analysis of the roller compactor according to the Sampling Plan defined in Part B.
  • Review of batch manufacturing records to identify trends or process changes impacting cleaning.
  • Scheduled method performance requalification for analytical assays.
  • Trend analysis of residue and microbiological data (if applicable) to identify incremental deviations.
  • Periodic review of cleaning procedure effectiveness and product portfolio to determine need for updates.

The frequency of continued verification activities should be risk-based, with higher-risk products or complex manufacturing processes warranting more frequent scrutiny.

Revalidation Triggers

Revalidation of the roller compactor cleaning procedure must be initiated when the following triggers occur:

  • Change in Product or Formulation: Introduction of a new API with a lower PDE/ADE or different physicochemical properties.
  • Change in Cleaning Procedure: Changes in detergent type, cleaning parameters (time, temperature), equipment design, or personnel.
  • Analytical Method Changes: Alterations impacting method sensitivity or scope of residue detection.
  • Equipment Maintenance or Modification: Repairs, replacement of components, or relocation requiring reassessment of residue risks.
  • Out-of-Specification Cleaning Results: Repeated cleaning failures or critical deviations.
  • Regulatory or Client Request: New regulatory guidance or audit findings mandating revalidation.

These triggers ensure the cleaning validation remains aligned with current manufacturing realities and regulatory expectations.

Annexures and Templates List

To facilitate standardized documentation and execution, the following annexures and templates support this roller compactor cleaning validation protocol:

Annexure/Template Purpose
Annexure A: Cleaning Validation Sampling Plan Details sampling locations, sample quantities, and frequency aligned with Part B.
Annexure B: Analytical Method Validation Report Documents method development, recovery, LOD, and LOQ performance for residues and detergents.
Annexure C: MACO Calculation Worksheet Template for PDE/ADE calculations incorporating site-specific inputs.
Annexure D: Cleaning Procedure (SOP Format) Stepwise standardized cleaning procedure for roller compactor equipment.
Annexure E: Cleaning Validation Sampling Record Field record for sampling details and chain of custody.
Annexure F: Cleaning Validation Summary Report Template Template for overall validation conclusions and acceptance.
Annexure G: Cleaning Validation Deviation and CAPA Log Tracking tool for non-conformance and corrective actions.
Annexure H: Continued Verification Plan Schedule Timetable and protocol for ongoing cleaning monitoring.

Conclusion

The roller compactor cleaning validation acceptance criteria and justifications presented herein align with current best practices in pharmaceutical manufacturing, emphasizing a risk-based PDE/ADE MACO approach with scientifically robust analytical validation. Method performance standards, detergent residue rationale, and a comprehensive governance framework—including deviation management, continued verification, and revalidation triggers—are integral to maintaining cleaning efficacy, patient safety, and regulatory compliance. By implementing the sampling plan detailed in Part B and adhering to this protocol, organizations ensure that roller compactor equipment is reliably cleaned and validated for oral solid dosage form production.

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