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Research ArticlePDA Paper

Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic

T. Cundell, D. Guilfoyle, T. R. Kreil and A. Sawant
PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 468-494; DOI: https://doi.org/10.5731/pdajpst.2020.012021
T. Cundell
1Microbiological Consulting, LLC, Scarsdale, NY;
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  • For correspondence: tonycundell@gmail.com
D. Guilfoyle
2Johnson & Johnson, New Brunswick, NJ;
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T. R. Kreil
3Takeda, Vienna, Austria; and
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A. Sawant
4Merck & Co. Inc., Kenilworth, NJ.
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  • Article
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    Figure 1

    Direct and indirect risks that may result in pharmaceutical drug shortages.

Tables

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    TABLE I

    Persistence of Coronaviruses on Inanimate Surfaces (28)

    Type of SurfaceVirusaInoculum (Viral Titer)Persistence (Temperature)
    SteelMERS-CoVHCoV10510348 h (20°C)8–24 h (30°C)5 d (21°C)
    AluminumHCoV1032–8 h (21°C)
    WoodSARS-CoV-11054 d (RT)b
    PaperSARS-CoV-110610510424 h3 h<5 min (All at RT)
    GlassSARS-CoV-1HCoV1051034 d (RT)5 d (21°C)
    PlasticSARS-CoV-1MERS-CoVSARS-CoV-1HCoV105105107105107≤5 d (22--25°C)48 h (20°C)6--9 d (RT)4 d (RT)2--6 d (RT)
    PolyvinylchlorideHCoV1035 d (21°C)
    Silicon RubberHCoV1035 d (21°C)
    Surgical Glove (Latex)HCoV5 × 103≤5 d (21°C)
    Disposable GownSARS-CoV-11061051042 d24 h≤8 h (All at RT)
    CeramicHCoV1035 d (21°C)
    TeflonHCoV1035 d (21°C)
    • ↵a MERS is Middle East Respiratory Syndrome virus; HCoV is Human Coronavirus; SARS-CoV-1 is Severe Acute Respiratory Syndrome virus.

    • ↵b RT is room temperature.

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    TABLE II

    Antivirus Activity of Representative Commonly Used Disinfectants and Sporicidal Agents in the Pharmaceutical Industry (34)

    Active IngredientProduct NameCompanyContact Time (Minutes)Formulation TypeEmerging Antiviral Claim
    Hydrogen PeroxideAccel (Concentrate)Virox Technology5DilutableYes
    PhenolicLpHSteris10DilutableYes
    PhenolicVesphene II seSteris10DilutableYes
    Sodium HypochloriteCloroxPro™ Clorox® Germicidal BleachClorox ProfessionalProduct Co.5DilutableYes
    Isopropyl alcoholDECON-AHOL WFI® Formula 70%Veltek AssociatesNARTUNo
    Hydrogen Peroxide and Peracetic AcidDECON-SPORE 200® PlusVeltek AssociatesNARTUNo
    Quaternary Ammonium;EthanolLysol® Disinfectant SprayReckittBenckiser LLC5RTUYes
    Hydrogen PeroxideOxy-1 WipesVorox Technology0.5WipesYes
    EthanolPURELL ProfessionalDisinfectant WipesGOJO Industries5WipesYes
    Sodium HypochloriteClorox Healthcare®Bleach Germicidal WipesClorox ProfessionalProducts Co.3WipesYes
    • View popup
    TABLE III

    Air Velocity and Number of Air Changes per Hour in Clean Rooms (39)

    Class of Clean roomAirflow TypeAverage Velocity (Ft./Min.)Air Changes/hr.
    ISO 8 (Class 100,000)N/M1–85–48
    ISO 7 (class 10,000)N/M10–1560–90
    ISO 6 (Class 1,000)N/M25–40150–240
    ISO 5 (Class 100)U/N/M40–80240–480
    • N is Non-unidirectional; M is Mixed Airflow; U is Unidirectional. Note: 10 ft/min equals 3.048 m/min.

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    TABLE IV

    Appropriate Personal Protective Equipment for Routine Pharmaceutical Manufacturing (40)

    Protective ClothingNon-Sterile Manufacturing AreasSterile Manufacturing Areas
    Plant uniform or plant uniform with overalls for high-risk product and environmentYesYes
    Hair/beard coveringsYesYes
    Safety glassesYesYes
    Dedicated shoes or shoe coveringsYesYes
    GlovesYes (if in direct product contact)Yes
    Face masksYes (if in direct product contact)Yes
    Enclosed respiratorsOnly if manufacturing high-potency, toxic drugs or infectious biological agentsOnly if manufacturing high-potency, toxic drugs or infectious biological agents
    Sterile clean room uniforms (coveralls), hoods, sleeves, goggles, face masks, and glovesNoYes, if in critical aseptic processing area
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    TABLE V

    Capacity of SARS-CoV-2 to Replicate in Primate and Human Cell Lines

    Cell LineCell Line OriginSARS-CoV ReplicationaReferences
    CHOChinese Hamster OvaryIncompatible(Kreil, 2020 Personal Communication)
    HEK293Human Embryonic CellsIncompatible(Kreil, 2020 Personal Communication)
    HT1080Human fibrosarcomaIncompatible(Kreil, 2020 Personal Communication)
    A549Human Adenocarcinoma CellsIncompatible50
    HUHHuman Liver CellsModerate50
    HEK293THuman Embryonic CellsModerate50
    VEROAfrican Green Monkey Kidney CellsHigh50
    • ↵a Incompatible is no growth, no cytopathic effect (CPE); Moderate is growth but no CPE; High is growth and CPE.

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    TABLE S-I

    Risk Assessment—Management of Human Resources during COVID-19 Pandemic

    ActivityRisk IdentificationRisk RatingRisk Mitigation/Critical Process Controls
    Recruitment of new staffLocal; Regional; National; InternationalLow to ModerateRemote interviews; Limit domestic and international travel; 14-day quarantine prior to starting work
    Training new hires and existing employeesLack of information;Issues not addressed in corporate policies and proceduresModerate to HighGMP compliance; Coronavirus awareness training;Symptoms identification
    Deployment of employeesDomestic; InternationalModerate to HighStaff functions conducted from home; Restrictions on nonessential domestic and international travel; deferment of large staff meetings
    Management and Supervision of EmployeesStaff and line functionsModerate to HighIllness recognition; Monitoring with thermal sensors; Universal wearing of non-medical face masks on the job
    Employee AttendanceEmployees working sick; Loss of human resources; Inability to commuteLowFlexibility in working hours;Stress importance of staying home when ill; Provide sickness benefits; Add company sponsored transportation when public transportation is unavailable
    • View popup
    TABLE S-II

    Risk Assessment—Management of Manufacturing Materials during COVID-19 Pandemic

    MaterialsRisk IdentificationRisk RatingRisk Mitigation/Critical Process Controls
    Pharmaceutical ExcipientsExcipients derived from plant, animal, or mineral origin; Excipients of synthetic or semisynthetic originLowSupplier awareness of potential COVID-19 risk; Standard duration of transit and hold times
    Drug SubstancesDrug substance of synthetic or semisynthetic originLowStandard duration of transit and hold times
    Packaging ComponentsGlass vials, stoppers and seals (Sterile products)Plastic container, heat induction seals and caps (non-sterile products)LowStandard duration of transit and hold times; automation of component handling; washing, depyrogenation and sterilization (sterile products)
    Labeling MaterialsLabels and package insertsLowReduce handling during label identification and reconciliation
    Incoming Potable WaterGround or surface waterLowCommunication with local water authority
    • View popup
    TABLE S-III

    Risk Assessment—Testing of Incoming Pharmaceutical Ingredients, Packaging Components, Intermediates, and Finished Products during COVID-19 Pandemic

    Materials—Sampling and TestingRisk IdentificationRisk RatingRisk Mitigation/Critical Process Controls
    Sampling of incoming materialsHuman intervention; Limited environmental controls in warehousesModeratePersonal protective equipment; sampling booths; labeling sampled containers
    Transportation to the testing areaTransition through the facilityLowDisinfection of the surface of containers, drums, shrink-wrap, and pallets
    Sample testingPersonnel handlingLowPersonal protective equipment; limited access to testing area; environmental controls
    Sample dispositionDisposalLowControlled destruction of samples
    • View popup
    TABLE S-IV

    Risk Assessment—Management of Plant Utilities during COVID-19 Pandemic

    Materials— Plant UtilitiesRisk IdentificationRisk RatingRisk Mitigation/Critical Process Controls
    Pharmaceutical-grade waterIncoming potable waterLowMaintain existing microbial monitoring program
    Pharmaceutical-grade plant airDistribution lines and delivery nozzlesLowAssure sanitary design
    Compressed gasesNoneLowMaintain existing microbial monitoring program
    HVAC systemPoor temperature, humidity, and air exchange; Recirculation and lack of segregationLow to ModerateReduced recirculation in more critical areas; Higher air change rates; High room ultraviolet germicidal irradiation
    Domestic and clean steamNoneLowNone
    VacuumDischargeLowReview vacuum discharge
    Washing facilitiesPoor design and opportunities for cross-contaminationLow to ModerateAccess to detergents, hot water, and hand sanitizing agents;Segregation of clean and dirty materials
    Waste and sewage disposalPoor separationModerateBackflow elimination;Segregation of clean and dirty materials
    • View popup
    TABLE S-V

    Risk Assessment—Representative Non-Sterile Drug Product (Compressed Tablet) during COVID-19 Pandemic

    Manufacturing ProcessRisk IdentificationRisk RatingRisk Mitigation/Critical Process Controls
    Incoming material sampling and testingSampling is an invasive processModerateSampling booths; Personal protective equipment (PPE)
    WarehousingLimited environmental controlLowImproved environmental control
    Ingredient weighingWeighing is an invasive processLow to ModerateEvaluate weighing booths and PPE
    Excipient size reductionEquipment cleaningLowUpgrade COP and CIP operations
    BlendingEquipment cleaningLowUpgrade COP and CIP operations
    Granulation— Dry Granulation—WetEquipment cleaningLowUpgrade COP and CIP operations
    CompressionEquipment cleaningLowUpgrade COP and CIP operations
    Bulk Tablet StorageNoneLowNone
    Packaging and labelingPackaging operations are labor intensiveLow to ModerateEvaluate HVAC Systems; Automation of component handling; PPE
    Finished goods warehousingPoor environmental controlLowImproved environmental control
    ShippingLack of chain of custodyLowDedicated carriers
    • Clean Out-of-Place (COP) and Clean In-Place (CIP).

    • View popup
    TABLE S-VI

    Risk Assessment—Representative Sterile Drug Products (Liquid-filled Stoppered Glass Vials) during COVID-19 Pandemic

    Manufacturing ProcessRisk IdentificationRisk RatingRisk Mitigation/Critical Process Controls
    Incoming material sampling and testingSampling is an invasive process in a warehouseModerateSampling booths and personal protective equipment (PPE)
    WarehousingLimited environmental controlLowImproved environmental control (IEC)
    Ingredient weighingWeighing is a labor-intensive processLow to ModerateEvaluate weighing booths and PPE
    Bulk solution preparationSolution preparation is a potentially invasive processLow to ModerateUse of Restricted Access Barrier Systems (RABS) and isolators
    Packaging component preparationComponent loading and unloading is a potentially invasive processLowAutomation of component handling; Depyrogenation and sterilization of vials and stoppers
    Sterile filtration and aseptic filling and SealingAseptic processing is a potentially invasive processLowUse of RABS and isolators
    Visual inspectionInspection is an invasive processLowHandling automation; IEC; PPE
    Packaging and labelingPackaging is an invasive processLowHandling automation;IEC; PPE
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PDA Journal of Pharmaceutical Science and Technology: 74 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 4
July/August 2020
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Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic
T. Cundell, D. Guilfoyle, T. R. Kreil, A. Sawant
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 468-494; DOI: 10.5731/pdajpst.2020.012021

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Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic
T. Cundell, D. Guilfoyle, T. R. Kreil, A. Sawant
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 468-494; DOI: 10.5731/pdajpst.2020.012021
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Keywords

  • COVID-19 pandemic
  • SARS-CoV-2 virus
  • Drug shortage
  • Supply chain
  • Employee screening
  • Risk Assessment
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