Your browser is out-of-date!

Update your browser to view this website correctly. Update my browser now

×

Home » ALG Compliance Tests » FDA Tests

FDA Tests

Cleanroom Services

Cleanroom Validation (IQ, OQ, PQ, ISO 14644)

  • Protocol Development
  • Risk Assessment
  • Installation Verification
  • HEPA and Room Certification
  • At Rest (static) and Operational (dynamic) environmental monitoring
  • Summary Report
  • On-site consulting and observation
  • Root cause analysis and CAPA
  • Investigative sampling
  • Microbial identification
  • Lab analysis
  • Final report

Cleaning and Disinfection

  • On-site review and observation of cleaning program
  • SOP review
  • Disinfection preparation
  • Mopping
  • Rinse procedures
  • Assessment of hard-to-clean areas
  • Final report

EM Program Design

  • Transition from PQ to routine
  • EM SOP development
  • Incubation and media equivalency study
  • Alert and action investigation
  • Training

Shutdown Response

  • AHU shutdown study protocol development
    Development of planned and unplanned SOPs
    On-site consulting and testing

Disinfectant Efficacy Study

  • Coupon based protocol study for microbial lethality based on disinfectant, contact time and challenge organisms

Media Fill and Process Simulation

  • Protocol development
  • Supply of growth promoted media
  • Incubation
  • Microbial identification
  • Final report

Cleanroom training

  • Aseptic technique training and qualification
  • Gowning training and qualification
  • SOP development

Inspection Readiness Auditing

  • Full system review
  • 483 or other observation remediation
  • Final report

Disinfectant Qualification

A controlled medical device manufacturing cleanroom environment requires a sound disinfectant qualification program. Disinfectants utilized within these environments must be validated to confirm their effectiveness for use. Proper rotation of the disinfectants can be determined based on the data collected in this study.

Environmental Monitoring Services

Cleanroom certification

Clean compressed gases

Clean compressed gases such as nitrogen, carbon dioxide, oxygen, and compressed air are used in the manufacturing process of medical, cosmetic, and nutritional products. Compressed gas systems must be free of harmful substances that may pose a serious risk to patients. The gas and the delivery system (compressed gas system) are typically tested for purity and the following contaminants: hydrocarbon (oil vapors), moisture (water vapor), bioburden, non-viable particulate contamination.

Clean steam monitoring

Clean steam contacting product, or product contact parts used for manufacturing of sterile products, must have the same microbiological and chemical quality as WFI water. ALG can provide sampling and testing services for your clean steam system.

Particulate analysis per USP

On-site Trained Contract Resources

ALG will provide trained resources to perform sampling at your facility. We even have the ability to assign a specific technician to your facility for an extended period of time.

Incubation and Media Equivalency Studies

ALG will assign a specialist to work with you to design and qualify your EM media and incubation parameters.

EM Program SOP Development

An assigned specialist will work with you to develop your EM program. We will provide guidance on transition from qualification to your routine program and we will develop your EM SOP.

Action Alert Program Development

Our staff has extensive experience in developing excursion response program, including SOP development, training and guidance on how to address adverse trends.

Qualified Media

ALG ensures all our media pass USP growth promotion testing. MRA provides the option for clients to purchase our growth promoted media to perform their own sampling. Just send the plates back to us and we will incubate and process the data for you.

EM Training and Educational Presentations

Our experienced specialists will travel to your facility to provide training for your staff. ALG provides professional training presentations on a wide range of topics, including EM and aseptic technique.

Microbial Identification

ALG has validated technology for the purpose of identifying microorganisms to species level. Our experienced microbiologists provide specific microorganism reports upon request.

On-site Investigational Support and Consulting

A specialist will be assigned on-site to your facility to assist or lead microbial contamination investigations. Our specialists have more than 25 years experience in root cause analysis and CAPA. We specialize in mold and Bacillus contaminations.

Pharmaceutical Testing

Stability Studies

USP <61><62> Suitability Tests

  • USP <61> <62> Suitability Tests (Methods Validation) Price Includes Complete Suitability Test including Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) and 4 Pathogens
  • Validation of the test method per product for USP <61> <62> includes growth promoted media for bacteria, yeast and mold, calibrated pipettes and balances and ATCC cultures. Each dilution is considered a sample. Products tested with and without neutralizers are considered separate samples.

USP <61><62> Product Testing

  • USP <61> <62> Product Testing (TAMC, TYMC Specified Microorganisms for 4 pathogens)
  • Testing can also be performed for: USP <61> Only or USP <62> Only
  • Test to determine total number of bacteria, yeast and mold in product including low limit detection of objectionable organisms.

Growth Promotion Testing of Plates USP <61<62>

  • Growth promotion of testing of media in accordance with USP <61> <62>.

Microbial Identifications

  • I.D. of Microorganisms to Genus and Species
  • Genus ID
  • Gram Stain
  • Coagulase
  • Colony Morphology
  • DNA
  • Identification of microorganisms. Includes microscopy, staining, morphology, biochemical tests, metabolic profiles to determine microbial ID for bacteria, yeast and mold. Utilizes validated Vitek 2 automated ID system.

Current USP <51> Preservative Effectiveness Test/EP 5.1.3

  • Determines efficacy of product/preservative systems with direct inoculation of microbial challenge organisms. Includes duplicate plating per USP <51> effective date October 2015.

USP <51> Suitability Test (Neutralizer Validation)

  • Includes duplicate plating and expanded neutralizer validation per USP <51> effective date October 2015.

Bacterial Water Analysis

  • Includes heterotrophic plate count, total gram negative count, presence of coliforms. Samples tested at multiple volumes (1ml, 10ml, 100ml) are considered separate samples.

Bacterial Endotoxin Test for Water Samples USP <85>

  • Bacterial Endotoxin Test for Water Samples USP <85> Gel Clot Method.
  • Detects and quantifies endotoxins in water samples from RODI/WFI systems.

USP <1112> Water Activity Testing (Aw)

  • USP <1112> Water Activity Testing (Aw) of Non-Sterile Pharmaceuticals (Solids/Oils/Creams).
  • Application of water activity for determination of potential microbial growth proliferation.

Bioburden Recovery Factor for Medical Devices

  • Bioburden validation to determine recovery factor for medical device compliance to sterilization validation.

Bioburden Test

  • Test to determine total number of bacteria, yeast and mold in product.

Current USP <71> Growth Promotion Test

  • Growth promotion testing of broths.

Current USP <71> Sterility Suitability Test

  • Validation of the test method per product for USP <71> sterility testing.

Current USP <71> Membrane Filtration Sterility

  • For large volume parenterals (LVP) call for quote.
  • Test for sterility of the sample, includes growth promoted media, validated equipment. Sample volume and sample quantity are per USP <71> Table 2 and Table 3.

Current USP <71> Direct Transfer Sterility Test

  • For large devices – call for quote.
  • Test for sterility of the sample, includes growth promoted media, validated equipment. Sample volume and sample quantity are per USP <71> Table 2 and Table 3.

AAMI Sterility Suitability

  • Validation of the test method.

AAMI Sterility

  • Test for sterility of the sample, includes growth promoted media and validated equipment.

USP <85> Bacterial Endotoxin Validation Test

  • Preliminary Tests.
    • Performed in Duplicate, Non-Inhibitory Concentration, Spiked Series, Standards, Unspiked Series.
  • Inhibition Series.
    • Performed in Quadruplicate, Validates LAL Method for Testing Product.
  • Validation of the test method per product for USP <85> endotoxin testing using gel clot method. Determines which dilution of product to carry out USP <85> inhibition/enhancement test.

USP <85> Bacterial Endotoxin Test of Product

  • Detects and quantifies endotoxins from gram negative bacteria in product.
  • Note: required endotoxin limit to be provided by client, and NIC to be performed.

USP <85> Endotoxin Challenge Vials (ECV)

  • ECVs are used to determine endotoxin control in depyrogenation validation studies.

Environmental Monitoring

  • Determines cleanliness of manufacturing areas, production rooms and cleanrooms. Includes growth promoted media for bacteria, yeast and mold. Includes validated incubation, laboratory analysis, colony counts, genus id and final reports.

Sterility Testing of Biological Indicators

  • Verifies microbial lethality of sterilization methods (steam sterilization, EO gas, etc.)

Biological Indicator (BI) Population Verification

  • Biological Indicator (BI) Population Verification (3 BIs Required)
  • Purity Testing
  • Verifies accuracy and purity of manufacturer’s label claim for spore populations.

Disinfectant Qualification

A controlled manufacturing cleanroom environment requires a sound disinfectant qualification program. Disinfectants utilized within these environments must be validated to confirm their effectiveness. Proper rotation of the disinfectants can be determined based on the data collected in this study. We have an internal collection of ATCC organisms ready for use onsite, plus the ability to identify and cryopreserve client environmental isolates.

Sterile Compounding

Environmental Monitoring (EM)

Samples can be shipped to ALG for laboratory analysis or ALG can provide qualified microbiologists to perform EM on-site. Enhanced reports, including graphical and statistical analysis, can be provided per client request.

 

Includes growth promoted media for bacteria, yeast and mold, calibrated air samplers and particle counters for sampling. This service includes validated incubation, laboratory analysis, colony counts, Genus ID and final reports.

Environmental Monitoring (EM) Program and Implementation

ALG will set up a USP <797> compliant EM program including standard operating procedures, sample site maps, action levels, frequency, room conditions, media, Corrective Action Preventative Action (CAPA) and retest.

ISO 14644 Certifications, PECs and SECs

Includes on-site HVAC engineer for HEPA integrity scans, air flow, velocity, differential pressure and particle counts for ISO 14644 certification. Quote based on number of cleanrooms, ISO 5 PEC’s, Chemotherapy and Number of HEPAs.

Air Flow Visualization (AFV)

Includes video smoke studies to evaluate air flow patterns within your laminar airflow equipment and cleanroom (your primary and secondary engineering controls.) AFV includes protocol on-site HVAC engineers, video with voice over, WFI smoke generator, featuring dynamic testing.

Staff Proficiency Testing and Program Implementation

We can train your staff!

  • Media Proficiency
  • Hand Hygiene
  • Aseptic Technique
  • Cleaning and Disinfection
  • Personnel Garbing
  • Sterile Gowning Proficiency

ALG will observe and test staff on these items to demonstrate and document proficiency with USP <797> and cGMP. Testing will include on-site microbiologist and growth promoted media. Includes media, validated incubation, laboratory analysis, colony counts, and final reports.

Staff Educational Programs

  • USP <797> Overview
  • cGMP Overview
  • Sterile Compounding Basics
  • Environmental Monitoring Certification
  • ALG will provide 1.5 hour didactic presentation including educational booklets, self-assessment questionnaire and personnel certificates.

USP <797> Compliance Gap Analysis

ALG will perform a GAP analysis report for USP <797> compliance assessment including on-site sterile compounding observation, facility design, E/M staff proficiencies, cleaning/disinfection, garbing, handwashing and CAPA.

Assessment of 3rd Party High Risk Compounder (503B)

Do you outsource some of your compounding to a 503B? How well do you really know them? Have you properly qualified your outsourcing provider? ALG will assess 503B operations for compliance to DQSA, USP <797> and cGMP.

Process Validation Simulations (ACD & Robotic Media Fills)

ALG will set up protocol-based media fill for TPN pumps, repeater pumps and compounding robots including growth promoted media in multiple type containers.

Sterilization Validation

ALG can provide validation of steam sterilization cycle using biological indicators and calibrated thermocouples to temperature map your autoclave and validate microbial lethality.

USP <71> Sterility and USP <85> Endotoxin Testing

ALG will test CSP per USP <71> and <85> including suitability and inhibition method validations.

Corrective Action Preventative Action (CAPA) Maintenance, Consulting and Program Setup

Includes CAPA procedures, out of specification reports, root cause investigations and CAPA trending.

Cleanroom Validation (Installation Qualification, Operational Qualification, Performance Qualification)

ALG will help verify the design, perform IQ, OQ and PQ and validate your new or upgraded cleanroom. Quote based on number of cleanrooms, ISO 5 PEC’s, Chemotherapy and Number of HEPAs.

Cleanroom Cleaning and Disinfection Program Implementation

ALG will set up cleaning and disinfection program including procedures for disinfectant types, preparation, contact time, frequency, rotation, equipment and schedules.

Environmental Services Pharmacy Cleanroom Disinfection

Includes an educational seminar, SOP review, cleaning observation, equipment compliance, disinfectant types, contact times and frequency.

Liquid Antimicrobial Efficacy

Ex-vivo Skin Model Testing of Antimicrobial Lotions or Sanitizers

This method utilizes a synthetic skin substance (Vitro-Skin®) designed simulate the topography and physical characteristics of human skin. Carriers prepared from the Vitro-skin® are inoculated with test organisms of interest and are treated in a manner designed to simulate use of the handwash, lotion or sanitizer. Following treatment, the carriers are neutralized and quantitatively assayed for surviving test organism. The resulting plates are incubated, the number of survivors is enumerated and a percent reduction is determined as compared to an untreated population control. No regulated reduction limits exist for this method as the results are typically used during the formulation process. Typical test organisms utilized in this method include Staphylococcus aureus and Escherichia coli, Salmonella enterica, Serratia marcesens, MRSA and additional pathogens of clinical, occupational or household relevance.

AOAC Method 966.04 Sporicidal Activity of Disinfectants

In this method, a series of porcelain cylinders and silk or Dacron sutures (“carriers”) are inoculated with the spores of Bacillus subtilis and Clostridium sporogenes and are desiccated. The carriers containing the dried spore film are then sequentially immersed into 10 mL of disinfectant and are exposed to the disinfectant for a predetermined exposure time. After exposure, the carriers are sequentially transferred to a liquid subculture medium specifically selected to neutralize the test substance active and to recover any surviving spores. The carriers are incubated and visually examined for the presence or absence of growth. Based on the desired claim and the requirements of the regulatory agency, the product must demonstrate kill on a predetermined number of carriers inoculated with test organisms applicable to the claim.

ASTM E2315 Time Kill Assay for Antimicrobial Agents

In this method, a sample of the product is inoculated with a suspension of a representative test organism. After a series of pre-selected exposure times, a sample is removed, neutralized and quantitatively assayed for surviving test organism. The resulting plates are incubated, the survivors are enumerated and percent and log10 reductions are determined for each time point as compared to a population control. Common test organisms used to evaluate hand sanitizers as recommended by the Tentative Final Monograph include but are not limited to: Staphylococcus aureus, Acinetobacter baumanii, Klebsiella pneumoniae, Streptococcus pyogenes, Pseudomonas aeruginosa, Burkholderia cepacia, and Serratia marcesens.

AOAC Method 965.12 Tuberculocidal Activity of Disinfectants

In this method, a series of porcelain cylinders or glass slides (“carriers”) are inoculated with Mycobacterium bovis and the carriers are dried. The carriers containing the dried organism film are then sequentially treated with the disinfectant in a manner intended to simulate its intended use and are exposed for a predetermined exposure time. After exposure, the carriers are sequentially transferred to a series of liquid media specifically selected to neutralize the test substance active and subsequently recover Myocbacterium. The subculture media is incubated and visually examined for the presence or absence of growth. For tuberculocidal claims, all subcultures must demonstrate kill (no growth) of Mycobacterium bovis.

AOAC Use Dilution Test for Liquid Disinfectants (Methods 964.02, 955.14 and 955.15)

In this method, a series of stainless steel cylinders (“carriers”) are inoculated with a representative test organism and the carriers are dried. The carriers containing the dried organism film are then sequentially immersed into 10 mL of disinfectant and are exposed to the disinfectant for a predetermined exposure time. After exposure, the carriers are sequentially transferred to a liquid subculture medium specifically selected to neutralize the test substance active and to recover any surviving test organism. The carriers are incubated and visually examined for the presence or absence of growth. Based on the desired disinfection claim and the requirements of the regulatory agency, the product must demonstrate kill on a predetermined number of carriers inoculated with test organisms applicable to the claim. Standard disinfection organisms include but are not limited to: Staphylococcus aureus, Salmonella enterica, and Pseudomonas aeruginosa. Additional pathogens of clinical, occupational or household relevance including fungi are often tested.

Antimicrobial Testing

Antimicrobial effectiveness

The Antimicrobial Effectiveness Test (AET) is designed to provide a laboratory test that gauges the level of biological activity possessed by the preservative system in a pharmaceutical or cosmetic product. The USP <51> and the BP/EP have specific requirements and different acceptance criteria for each type of pharmaceutical product. When performed according to USP <51>, five indicator organisms are utilized for the purpose of challenging the preservative system in a product. Three of the five USP indicator organisms, Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus, address the growth of bacteria. Candida albicans is the representative yeast, while Aspergillus niger is a mold. Other organisms can be incorporated into the test as customer and product needs dictate.

Antimicrobial properties evaluation

ALG provides a comprehensive program for evaluation of antimicrobial properties of compounds, liquids, or solid materials. Depending on the compound, testing may consist of method development, Time Kill studies, MIC and MBC. Studies can be performed utilizing bacteria, fungi, or viruses. ALG can customize the studies or perform them based on ASTM, USP, AOAC, or AATCC protocols.

Bacteria and mold identification

Bacterial and mold isolate characterization services include the use of BioLog OmniLog® Microbial ID System and the BioLog MicroStation® MicroLog™ BioLog.

Bacterial endotoxin

The Limulus Amebocyte Lysate (LAL) test is an in vitro assay used for detection of pyrogenic substances (endotoxin) in sterile parenteral drugs, in-process manufacturing samples, cleaning validation rinse samples, and medical devices. Limulus amebocyte lysate is an aqueous extract of blood cells (amebocytes) from the horseshoe crab, Limulus polyphemus. The LAL test can be performed by any of the following methods - Kinetic Turbidimetric or Kinetic Chromogenic.

Bacteriostasis and fungistasis

Bacteriostasis and fungistasis testing is required by all major pharmacopeias as a means of validating the Sterility Test. This essential step should be conducted on all new products or materials initially submitted for testing and should be repeated periodically to assure continued compatibility with established testing procedures.

Bioburden / microbial enumeration test

The microbial enumeration test, also called the bioburden test or the microbial load test, is performed to monitor the microbial content in raw materials, in-process samples, and finished product in the pharmaceutical, biological, cosmetics, nutritional products, and medical device industry. The FDA expects companies to monitor the bioburden load in products used for humans and animals. The bioburden test can be performed by several methods based on the nature of the material tested.

Biological indicators (BIs) for sterility

ALG can provide biological indicators (BI) designed to meet the ANSI/AAMI/ISO/EN 11138 standards and USP guidelines. We purchase our BIs from selected vendors. BIs provided by ALG are tested for spore population and identity. D value verification can be arranged per customer request.

Container closure studies

A container closure system refers to the sum of packaging components that together contain and protect the drug dosage form. Regulatory agencies require that companies must demonstrate that the container closure system used to package a drug or medical device will protect the product from microbial contamination or preserve the sterility for the life of the product. The product container closure system can be tested by physical (Dye Leak test) or microbiological means (microbial immersion test).

Disinfectant efficacy studies

All disinfectant, sanitizer or sporicidal solutions must pass testing requirements by the EPA, FDA, and EU regulatory bodies in order to be licensed. Testing requirements for licensing are very limited and specific and do not represent actual use. FDA requires that drug and medical devices manufacturers validate the disinfectant to demonstrate the efficacy under use conditions and microbial flora specific to the manufacturing site. European disinfectant testing requirements are indicated in CEN/TC 216 (European Committee for Standardization Technical Committee 216 – Chemical Disinfectants and Antiseptics).

Media incubation and growth promotion

ALG provides media, growth promotion and sterility check studies, incubation, plate inspection, and reporting 7 days a week.

Microbial bactericidal concentration (MBC)

Microbial inhibitory concentration (MIC)

Microbial limits/enumeration test

The Microbial Limits Test (or Microbial Enumeration Test) is designed to perform the qualitative and quantitative estimations of specific viable microorganisms present in samples. It includes tests for total viable count (bacteria and fungi) and screening for pathogenic organisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella, Clostridium, and Escherichia coli. The type of pathogen screening will depend on the product (e.g., oral products are typically tested for absence of E. coli and Salmonella). When test samples have antimicrobial activity or when they include antimicrobial substances, these antimicrobial properties are eliminated by dilution, filtration, neutralization, inactivation, or other appropriate means.

Particulate analysis per USP

Sterility testing – including rapid sterility

ALG provides sterility testing for biopharmaceuticals and medical devices that claim to be sterile and free from microorganisms. Testing is performed in an ISO 5 BSC located in an ISO 7 cleanroom. The sterility test is performed in accordance with USP/EP requirements for biopharmaceuticals or AAMI guidelines for medical devices. The test must be validated using a method suitability or bacteriostasis and fungistasis test to ensure the material does not have inhibitory properties that affect microbial growth.

ALG also offers rapid sterility testing with a 7-day turnaround time utilizing the BacTALERT® 3D System.

Water sampling and testing

The United States Pharmacopeia (USP) defines several types of water including: Purified Water, Water for Injection, Sterile Purified Water, Sterile Water for Injection, Sterile Bacteriostatic Water for Injection, Sterile Water for Inhalation, and Sterile Water for Irrigation. However, there are two basic types of water preparation, Water for Injection (WFI) and Purified Water. The analytical standards for these two types of water are very similar, differing in the fact that Water for Injection has stricter bacterial count standards and must also pass the bacterial endotoxin test.

The source water supplied to the purification system for preparation of USP water must comply with drinking water standards as defined by the United States Environmental Protection Agency in the National Primary Drinking Water Regulations or equivalent international regulations. The following tests are required to meet USP and EP test requirements:

  • Conductivity
  • Total Organic Carbon (TOC)
  • Bioburden (plus bacterial endotoxin in the case of WFI)
  • Water used to manufacture products for Europe must meet EP test requirements for heavy metals and nitrates.

Molecular Cell Biology & Virology

USP <63> Mycoplasma Tests, EP 2.6.7, Mycoplasmas

  • Culture (Direct) Method
  • Indicator Cell Culture (Indirect Method)
  • Inhibitory Substances (Mycoplasmastasis) Method
  • Nucleic Acid Amplification Techniques (NAT)
  • MicroSEQ Mycoplasma Real-Time PCR Assay
  • Comparability and Suitability Studies for Use of NAT
  • Validation of NAT

USP <87> Biological Reactivity Tests, ISO 10993-5, Cytotoxicity

  • Agar Diffusion Test
  • Direct Contact Test
  • Elution Test
  • MTT Assay

Custom Studies in Molecular Cell Biology and Virology

  • Assay development and Validation
  • PCR
  • ELISA
  • DNA Electrophoresis (Supercoiled DNA Content, Restriction Digest)
  • Protein Electrophoresis (SDS-PAGE R & NR) and Immunoblotting
  • Total Protein
  • Nucleic Acid Concentration and Homogeneity
  • Cell Line Generation
  • Cell Culture Expansion
  • Cell Viability Assay
  • Molecular Cloning and Expression Systems
  • Potency and Safety
  • Viral Cell-based Assays (Plaque, Focus and TCID50)
  • ViralSEQ Mouse Minute Virus (MMV) Real-time PCR Assay
  • Impurity
  • resDNASEQ CHO DNA Real-time PCR Assay
  • Residual DNase Activity Assay
  • Residual RNase Activity Assay
  • Residual Protease Activity Assay

Cosmetics

CTFA/PCPC (PET)

CTFA/PCPC PET will test cosmetic for preservative effectiveness with multiple challenge organisms to determine microbial lethality over time. Rechallenge at day 14 will add more robust methodology for overall preservative effectiveness.

TAMC & TYMC

Total count will be performed upon sample receipt to determine overall microbial cleanliness and baseline for pet.

CTFA/PCPC M-1/M-2

Validation of the test method per product for CTFA/PCPC M-1/M-2 includes growth promoted media for bacteria, yeast and mold, calibrated pipettes and balances and ATCC cultures. Each dilution is considered a sample.

CTFA/PCPC M-1/M-2

CTFA/PCPC M-1/M-2 Determination of the Microbial Count of Cosmetic Products & M-2 Examination for Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa

  • Testing can also be performed for: M-1 Only or M-2 Only

Test to determine total number of bacteria, yeast and mold in product including low limit detection of objectionable organisms.

USP <1112>

  • USP <1112> Water Activity (Aw) of Non-Sterile Pharmaceuticals (Solids/Oils/Creams)
  • Application of water activity for determination of potential microbial growth proliferation.

Other Services

Disinfectant Efficacy Testing USP <1072>

Coupon based protocol study for microbial lethality based on disinfectant, contact time and challenge organisms.

Container Closure Integrity PDA TR27, USP<1207>

Protocol challenge with Brevundimonas diminuta immersion, incubation, observation, ID and final report.

Cleanroom Validation (IQ, OQ & PQ) ISO 14644

Includes protocol development, install verification, HEPA testing, ISO certification, static/dynamic monitoring and summary reports.

Water System Validation (IQ, OQ & PQ) USP <1231>

Includes protocol development, install verification, fluid engineering, chemical/microbiology testing and summary reports.

Cleaning Verification Study

Includes pre-EM, cleaning audit, post-EM and final report.

ISO 14644 Room, BSC, LFH, and Isolator Certifications

Includes filter leak scan, velocity profile, total airflow, air exchange rates, particle counts, return air flow, light levels, noise levels, temperature, relative humidity (Rh), and room differential pressure readings. USP <797> requires recertification every six months.

Airflow Pattern Testing and Video USP <797> and ISO 14644

Price per number of cleanroom, BSC and HEPAs.

ISO 11135 EO Sterilization Validation

Includes protocol, BI population, sterility and final report.

ISO 11137 Gamma Sterilization Validation (VD Max Method 1, Method 2)

Includes bioburden recovery, sterility and suitability.

Cleanroom Contamination Control

Includes on-site observation, intensive sampling, lab analysis, ID’s and final report.

Cleaning and Disinfecting Consulting & Cleaning Validation

On-site review and observation of cleaning function, SOP review, disinfectant preparation, mop strokes, coverage, contact times, rinse procedures, hard to clean areas and final report.

Media Fill for Process and Equipment

Includes protocol, media GPT, incubation, observation, ID’s and final report.

Compressed Air Testing

Includes on-site testing, calibrated equipment and media for viables, non-viables, hydrocarbons, moisture, specialty gases and purity.

Training Services

Includes: On-site visit with 1.5 hour didactic lecture, educational booklets, proficiency self-test and individual attendance certificate. Maximum of 25 attendees.

Aseptic Processing Training

Aseptic technique discussion for contamination control, cleaning/disinfection, garbing (PPE), biological safety and cross contamination.

Cleanroom Basics Training

Includes CR design and operation, gowning, basic microbiology & principles of disinfection, environmental monitoring and aseptic technique.

Environmental Monitoring Training

Includes sample sites, risk assessment, viable/non-viable monitoring, media, GPT, equipment, calibration, volume, action/alert levels, techniques, PDA TR13, USP <1116>, EU Annex 1 and USP <797> specification.

Pharmaceutical Water Systems Training

Includes DI, RODI, WFI. Discuss water quality, system design, monitoring. USP/EPA criteria, sampling, TOC, conductivity and validation.

cGMP Training

Training for current good manufacturing practices including standard operating procedures, good documentation practices, code of federal regulations, quality systems, personnel training and FDA oversight.

Aseptic Water Sampling Training

Includes water system design and operation, water quality, water microbiology, disinfection, sampling procedures, aseptic technique, dead-legs.

USP <797> Sterile Compounding Training

Includes USP <797> sterile compounding regulations including risk levels, PEC/SEC design, environmental monitoring, action levels, CAPA, cleaning/disinfection, BUD, sterility, endotoxin, stability, sterilization and staff proficiencies.

Cleaning and Disinfection Training

Includes disinfectant types, API, contact times, lethality, frequency, disinfectant preparation, mop strokes, coverage, direction, SOP’s training and corrosiveness.

Preservative Effectiveness Training

Includes USP <51> and CTFA procedures and categories. Discuss techniques, challenge organisms, pooling, neutralizer validation, toxicity and pass/fail criteria.