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GMP Testing Laboratory · Allentown, PA | Build Your Audit Package

Technology & laboratory infrastructure

Advanced platforms. Connected systems. Personal support.

PlumGXP connects modern microbiology, controlled laboratory infrastructure, digital quality systems and responsible operating practices—while remaining small enough to know the client, the product and the decision behind every sample.

  • Traditional + rapid methods
  • Controlled environments
  • Digital visibility
  • Direct scientist access
PLUMGXP
PLATFORM
Scientific
Technology
Controlled
Infrastructure
Connected
Laboratory
Responsible
Operations
More than an instrument list

Technology is valuable when it improves the decision.

An instrument produces data. It does not determine whether the method fits the product, explain an unexpected recovery or connect a result to the manufacturing process. PlumGXP pairs every platform with scientific review, qualification and direct client access.

The PlumGXP difference

Advanced technology without institutional distance.

Clients gain access to multiple testing pathways, modern data systems and resilient laboratory infrastructure without losing the ability to speak directly with the people performing and reviewing the work.

Method selection

The newest method is not automatically the right one.

Product matrix, sample volume, release need, intended use and regulatory pathway determine the appropriate platform.

Visibility

The sample should not disappear after receipt.

Connected internal systems and the client portal create clearer status, ownership and communication throughout the testing lifecycle.

Scientific technology

Multiple platforms, selected around the product.

PlumGXP is building complementary capabilities so clients are not forced into one technology when formulations, sample types and quality decisions require different approaches.

01 / STERILITY

Traditional and rapid sterility testing

Three pathways allow method selection around filterability, matrix, sample availability, release timeline and intended use.

Platforms

  • Traditional USP <71> membrane filtration
  • Traditional direct inoculation
  • ScanRDI viable-cell detection
  • Celsis ATP-bioluminescence

Client advantage

One laboratory relationship can support traditional and rapid product families with coordinated validation and investigation planning.

Explore sterility testing →
02 / IDENTIFICATION

Complementary microbial identification

Fast routine identification and sequence-based resolution provide options when the organism matters to the investigation.

Platforms

  • Autobio MALDI-TOF
  • MicroSEQ genetic identification
  • Culture and isolate characterization

Client advantage

No single identification system resolves every organism. Complementary methods allow the approach to follow the isolate and the question.

Explore microbial identification →
03 / ENDOTOXIN

Quantitative and rapid endotoxin options

Flexible endotoxin platforms support products, water, raw materials, components and time-sensitive testing programs.

Platforms

  • Sievers Eclipse kinetic testing
  • Charles River PTS
  • Product-specific inhibition/enhancement
  • Animal-free reagent options

Client advantage

Platform selection can consider sample volume, throughput, timing, matrix and program requirements.

Explore endotoxin testing →
04 / WATER & ANALYTICAL

Automated water and analytical testing

Quantitative instruments support routine release, qualification, investigations and meaningful trend evaluation.

Platforms

  • Sievers TOC with autosampler
  • Conductivity and pH systems
  • Automated colony counting
  • Particulate, physical and analytical testing

Client advantage

Automated data collection and consistent workflows strengthen traceability and reduce dependence on subjective manual interpretation.

Explore water testing →

Platform availability is application-specific. Current readiness, validation status and suitability for a particular product are confirmed during program assessment.

Purpose-built environments

Infrastructure designed to protect the sample, the method and the result.

Controlled testing areas separate activities according to risk and method requirements while supporting efficient movement of people, materials and samples.

01

Sterility suite

ISO 5 testing conditions within an ISO 7 room, supported by an ISO 8 anteroom for controlled entry and transition.

02

Water testing

Dedicated ISO 5 work areas support controlled handling for pharmaceutical water microbiology.

03

Nonsterile testing

ISO 5 work areas support controlled sample manipulation for applicable nonsterile microbiology workflows.

04

USP Purified Water

An onsite USP Purified Water system supports laboratory operations and controlled method execution.

ISO 7 room

ISO 5 Sterility Testing Area

Controlled traditional sterility testing by membrane filtration or direct inoculation.

Entry

ISO 8 Anteroom

Controlled personnel and material transition.

Separate workflows

ISO 5 Work Areas

Water and applicable nonsterile sample handling.

Operational resilience

Business continuity is part of sample protection.

The PlumGXP generator supports the entire laboratory and office environment—not only selected outlets—helping preserve critical conditions, monitoring, data access and communication during a power interruption.

Whole
facility

Generator backup

Laboratory and office operations are supported as an integrated system because sample continuity depends on equipment, monitoring, IT and people remaining connected.

Incubation

Supports continuity of controlled conditions for active microbiological studies.

Cold storage

Helps protect samples, reagents, cultures and controlled-temperature materials.

Monitoring

Supports facility and equipment monitoring, alarms and event visibility.

Data & communication

Maintains access to laboratory systems, records and client coordination.

Laboratory OperationsIllustrative view
Sample statusOn track
Asset statusCurrent
Quality actionsReview
Connected digital laboratory

Technology behind the result—and behind the operation.

PlumGXP’s digital environment connects quality, sample execution, equipment, client commitments and business operations so the team can see what requires attention before it becomes a delay.

Quality managementDocuments, training, events and actions
Sample trackingReceipt, workflow, review and reporting
Asset managementQualification, calibration and maintenance
Compliance calendarUpcoming recurring requirements
Client relationship managementPrograms, commitments and communication
Colleague portalLive KPIs, priorities and capacity
The client portal

The laboratory should not become a black box.

The PlumGXP client portal is designed to provide visibility from receipt through reporting while preserving direct access to the people responsible for the work.

01

Received

Confirm arrival and accessioning.

02

Scheduled

Understand the planned workflow.

03

Testing

See current testing status.

04

Quality review

Know when data are under review.

05

Reported

Access completed documents.

Sample visibility

Follow samples and testing progress without relying on repeated status-request emails.

Document access

Retrieve reports and relevant program documents through a consistent client-facing location.

Program history

Maintain an organized view of prior submissions, activity and documentation.

KPI insight

Review program-level performance and trends when included within the client relationship.

Shared access

Allow authorized quality, operations and leadership users to work from the same information.

Audit readiness

Reduce time spent locating testing records and assembling supporting information.

The portal provides visibility. It does not replace a person. When a result, delay, method question or investigation needs discussion, clients can still reach the PlumGXP team directly.

Responsible choices within controlled operations
Responsible laboratory operations

More thoughtful choices, built into routine work.

Laboratories require energy, single-use materials and controlled environments. PlumGXP looks for practical opportunities to reduce waste and resource use without compromising contamination control, employee safety, data integrity or GMP requirements.

01 / ENERGY

Efficient facility use

Occupancy-responsive lighting turns off when rooms are unoccupied, and high-efficiency incubators and freezers are selected where practical.

02 / LAB MATERIALS

Specialized recycling

Eligible cleanroom apparel, gloves and pipette tips are collected through Polycarbin sustainability and recycling programs.

03 / PACKAGING

Reuse before disposal

Suitable incoming shipping materials are reused when appropriate, while cardboard and eligible packaging are directed to recycling.

04 / PURCHASING

More responsible selection

Energy-efficient equipment and reduced-waste or more sustainable supplies are considered when technically appropriate and available.

05 / DIGITAL

Less paper dependence

Digital quality, operational and client workflows reduce unnecessary printing and repeated paper-based communication.

06 / CONTINUITY

Protecting work already performed

Resilient utilities and backup power help reduce the risk of losing samples, studies and temperature-controlled materials during interruptions.

Control comes first.

Reuse, recycling and sustainable purchasing decisions are implemented only when they remain compatible with contamination control, validated processes, product protection and applicable quality requirements.

Frequently asked questions

Understanding the PlumGXP platform

Does PlumGXP recommend the newest method for every product?

No. Method selection considers the product matrix, sample volume, testing objective, turnaround need, regulatory pathway and required validation. Traditional testing may remain the strongest choice for some products.

What happens if power is interrupted during testing?

Generator backup supports the laboratory and office environment, including critical equipment, monitoring and IT systems. Event assessment and any study-specific actions would still follow controlled quality procedures.

Does the client portal replace direct communication?

No. The portal improves routine visibility and document access. Clients retain direct access to PlumGXP personnel when a method, result, timing concern or investigation requires discussion.

Can every client use every technology platform?

Not automatically. Platform readiness, product compatibility, sample requirements, method suitability and validation must be evaluated for the intended application.

How does PlumGXP approach sustainability in controlled laboratory areas?

PlumGXP uses specific practices such as occupancy-responsive lighting, efficient equipment, specialized recycling, packaging reuse and digital workflows. No sustainability practice is implemented at the expense of GMP controls, safety or contamination prevention.

Start with the product and the decision

Technology should bring the laboratory closer to the client.

Tell us what you are trying to release, qualify, investigate or improve. PlumGXP will help identify the most appropriate testing pathway and support structure.