Pharma / Food GMP · Continuous Key-Parameter Acquisition & Compliance Audit
For GMP-compliant production, a protocol gateway continuously acquires key parameters such as temperature, pressure and flow, while the G220 adds screen-level review and OCR records — turning manual batch records into automatic, traceable electronic evidence.
Core solution for this scenario
I. Industry Pain Points
Typical challenges for Pharma / Food / GMP Compliance Manufacturing in equipment O&M and data acquisition.
- GMP requires continuous monitoring and batch records of key process parameters (temperature, pressure, flow, rotation speed); traditionally this relies on manual periodic reading — lagging, error-prone and slow to prepare for audit.
- Reactors, sterilizers, CIP and other equipment use many PLC / instrument brands, with parameters scattered across different HMIs, hard to acquire continuously and uniformly.
- On a deviation, manual records make it hard to quickly trace “who, when, changed what,” so deviation investigation (OOS / deviation handling) is time-consuming.
- Food and pharma are regulated, sensitive industries; data must be retained locally and remote access must be compliant.
A well-known traditional Chinese medicine (TCM) preparation enterprise, with 3 production lines involving 20+ devices (mixed brands including Siemens / Mitsubishi PLCs, temperature transmitters, humidity sensors), previously used manual reading + Excel entry for batch records; before audit inspection it had to halt production for 2 weeks to sort paper records, with ~5% of key parameters missing. After deploying the G160 + G220 combination, all device key parameters are automatically and continuously acquired, batch-level data is exported as audit reports with one click on the DVS platform, audit preparation was cut from 2 weeks to 2 days, key-parameter coverage reached 95%+, meeting 21 CFR Part 11 electronic-record compliance.
II. Solution
Build a "screen layer + protocol layer" dual-source data closed loop with the AIXOT non-intrusive gateway combination.
- AIS-G160 Industrial Protocol Gateway unifies acquisition from reactors, sterilizers, CIP and other equipment PLCs and instruments, models by process segment, continuously records key parameters and pre-screens anomalies at the edge.
- APM-G220 Non-intrusive Smart Tuning Gateway non-intrusively takes over the IPC-controlled device screen for parameter review and OCR text records, precipitating key on-screen values into traceable electronic evidence and covering points the protocol does not expose.
- Automatic alarm on parameter breach, linked to the batch number; during deviation investigation the OCR record and trend curve can be replayed directly — turning audit prep from “flipping paper records” into “one-click export.”
- All data is retained locally; remote access goes through the private / intranet network, meeting GMP data-integrity and compliance requirements.
III. Deployment Steps
An executable path from interface inventory to a standardised closed loop.
- Map the GMP key-parameter list and the corresponding equipment / PLC / instrument interfaces
- Configure the G160 protocol template and acquisition period; build a parameter model and thresholds per process segment
- The G220 takes over the key host screen, records a parameter-review script and adds OCR records, covering protocol-unexposed points
- Automatic alarm on parameter breach linked to the batch number; anomalies enter the deviation flow
- Establish an electronic-batch-record export SOP; on audit, one-click generate trends and the OCR evidence chain
IV. System Integration & Data Connectivity
Standardised connection points with MES / SCADA / PLC / quality systems.
- Connect to MES / electronic batch record: parameters and OCR records archived by batch number
- Connect to LIMS / quality system: deviation investigation directly pulls parameter trends and OCR evidence
- Connect to SCADA: key parameters enter the central monitoring screen
- Complement with AIS-T100 Video OCR Data-Collection Gateway OCR: fallback acquisition of protocol-less screen points
V. Value & Quantified Metrics
Measurable benefits from the non-intrusive solution.
VI. Deployment Boundaries & Compliance Red Lines
Compliance & applicable boundaries
Pharma and food are regulated, sensitive industries; data must be retained locally, and 4G remote access must use a private / intranet network — public-cloud connection is strictly forbidden. The G220 applies only to IPC / PC-controlled devices with video output and USB input; pure controller protocol acquisition is handled by AIS-G160 Industrial Protocol Gateway.
VII. FAQ
High-frequency questions for the Pharma / Food / GMP Compliance Manufacturing scenario.
Can manual batch records be replaced?
G160 continuous acquisition + G220 OCR records automatically precipitate key-parameter electronic evidence, replacing most manual reading and supporting one-click audit export.
How are protocol-unexposed device points acquired?
The G220 takes over the IPC-controlled device screen for OCR records, covering protocol-unexposed points and complementing G160 protocol data.
How to investigate a deviation quickly?
Automatic alarm on parameter breach linked to the batch number; during investigation, replay the OCR record and trend curve to locate “who, when, changed what.”
Is data retained compliantly?
All data is retained locally; remote access goes through the private / intranet network, meeting GMP data-integrity and traceability requirements.
In the 'Pharma / Food / GMP Compliance Manufacturing' scenario, which CNC, PLC and injection-molding brands can G160 connect to?
AIS-G160 ships a 500+ industrial-protocol driver library, verified for CNC systems from FANUC, Siemens, Mitsubishi, SYNTEC; PLCs from Siemens, Mitsubishi, OMRON, Delta, Inovance; and injection machines from Techmation, Keqiang, Mediatek, Chen Hsong. See the 'Device Compatibility' list on this page for specific models; some legacy devices require on-site confirmation of network/extension-module conditions.
Related Scenarios & Products
Electronics Assembly / SMT
Multi-brand device data acquisition and correlation analysis
→ View ScenarioCNC Machine Tools Brands & Models Supported by G160
AIS-G160 ships a 500+ industrial-protocol driver library with native brand support for dedicated controllers (CNC, injection molding, robots) that generic gateways struggle to connect. Below are mainstream brands and models verified for data acquisition (some models require on-site confirmation of interface conditions).
| Brand | Supported Models / Comms |
|---|---|
| FANUC | All systems with an Ethernet port can communicate; for systems without an Ethernet port, on-site confirmation is required to determine whether an expansion module can be added |
| SYNTEC | System version 10.116.16X or later |
| Mitsubishi | E70, M70, M700, E80, M80, M800 |
| BROTHER | Systems with an Ethernet port |
| SIEMENS | 828D, 828DSL, 840DSL, 808D/808DSL (Ethernet-capable) |
| Haas | Full Ethernet series / full serial-port series |
| KND | Systems with an Ethernet port |
| GSK | All Ethernet-capable systems; 988 series, 25imc, etc. |
| Other Ethernet-capable brands | HNC, Mazak, HEIDENHAIN, Huazhong CNC, etc. can also be connected via the edge gateway |
PLC (Programmable Logic Controller) Brands & Models Supported by G160
AIS-G160 ships a 500+ industrial-protocol driver library with native brand support for dedicated controllers (CNC, injection molding, robots) that generic gateways struggle to connect. Below are mainstream brands and models verified for data acquisition (some models require on-site confirmation of interface conditions).
| Manufacturer / Brand | Typical Series & Models | Comms | Protocol / Driver |
|---|---|---|---|
| Siemens | S7-200 (PPI), S7-300/400 (MPI), S7-200 Smart, S7-1200, S7-1500, LOGO! | Serial / Ethernet | S7 PPI, MPI, S7comm, Modbus TCP |
| Mitsubishi | FX0/FX1/FX2, FX3U/3G, Q series (Q00J/Q00/Q02/Q02H/Q06H/Q12H/Q25H, QnU Q00U~Q26U, QnA/A series), FX3U-ENET, FX5U, QJ71E71 | Serial / Ethernet | Mitsubishi MC, MELSEC, SLMP |
| Rockwell AB | Micro800 | Ethernet | EtherNet/IP |
| LS | XGT, XGB, XBC-DN32U | Serial / Ethernet | Proprietary protocol |
| Modbus | Standard Modbus devices | Serial / Ethernet | Modbus RTU / ASCII / TCP / RTU over TCP |
| Schneider | Full range | Serial / Ethernet | Modbus RTU / TCP |
| Power utility protocols | Power utility terminals | Serial / Ethernet | IEC 60870-5-101, DNP3.0, IEC 60870-5-104 |
| HollySys | LE/LK220, LK210 | Serial / Ethernet | Modbus RTU |
| THIN | XD/XL, XC | Serial / Ethernet | Modbus TCP |
| Inovance | H1U/H2U, H3U, H5U | Serial / Ethernet | Modbus |
| OMRON | CJ/CS, CV, CP | Serial / Ethernet | OMRON FINS, Ethernet TCP |
| FATEK | Full range | Serial / Ethernet | Proprietary protocol |
| Delta | DVP, AS228T | Serial / Ethernet | Modbus RTU / TCP |
| Panasonic | FPX, FP | Serial / Ethernet | MEWTOCOL_COM |
| Haiwell | Full range | Serial | Modbus RTU / ASCII |
| Kewei | LP series | Serial | Modbus RTU / proprietary protocol |
| Meters / Environmental / Building Automation | Smart meters, environmental monitoring, building-automation devices | Serial / Ethernet | CJ/T188, DL/T645 (2007/1997), HJ212, BACnet MS/TP, BACnet IP |
| OPC UA | Software / devices supporting OPC UA | Ethernet | OPC UA |