회사 소식 Demystifying Pharmaceutical Packaging Standards: FDA, EU GMP, and Machinery Validation (DQ/FAT/IQ/OQ/PQ)

In the global pharmaceutical market, precision in solid dosage packaging is mandated by strict regulatory frameworks. Whether you are producing for the US market under FDA 21 CFR Part 211 or the European market under EudraLex Volume 4, your equipment must guarantee that every bottle contains the exact prescribed count—no more, no less.

1. Material Integrity and Hygienic Design (cGMP)
According to cGMP principles, any machine part that comes into direct contact with the product must be non-reactive, non-absorptive, and non-contaminating.

The Standard: Smooth surfaces (Ra $le$ 0.8μm) and the use of SUS304 or 316L stainless steel to prevent microbial growth.
Case Study (SED-8S): The SED-8S Automatic 8-Channel Electronic Counting Machine utilizes a corrugated vibrating plate design to move tablets and capsules. This allows for a tool-less disassembly of all contact parts, facilitating the "Cleaning Validation" required by GMP to prevent cross-contamination during product changeovers.

2. The Challenge of "Dust Integrity" in Counting

One of the most common causes of audit failure in counting lines is inaccurate tallies caused by ambient dust from uncoated tablets or friable capsules.

The Standard: Sensors must be able to distinguish between a solid dosage form and airborne particulates.
Case Study (SED-8S): To meet these high standards, the SED-8S is equipped with proprietary anti-high dust photoelectric sensing technology. This ensures that even in environments with significant powder shedding, the counting logic remains stable, and the error rate stays below international thresholds.

3. The Validation Roadmap: DQ, FAT, IQ, OQ, PQ
A compliant machine must be accompanied by a validation lifecycle that proves it is fit for its intended use. Here is how a professional validation process should look, using the SED-8S as a benchmark.

FAT (Factory Acceptance Test)
Before the machine leaves the supplier, a FAT is conducted to ensure the build matches the Design Qualification (DQ).

• Example: During the FAT for an SED-8S, engineers verify the production speed achieves the promised 10-40 bottles/minute and that the SICK sensors correctly identify "Bottle Jams" or "No Bottle" scenarios.

IQ (Installation Qualification)
IQ verifies that the equipment is installed in an environment that supports its technical needs.

• Example: For the SED-8S, IQ documentation tracks the verification of the 220V/50HZ power supply and the connection to a 0.6Mpa compressed air source with a flow rate of 3.5L/min.

OQ (Operational Qualification)
OQ tests the machine’s functional limits.

• Example: Testing the Delta HMI and Schneider emergency stop circuits. We verify that the 8-channel vibration system delivers a uniform flow for various materials—ranging from small pills (5.5mm) to large capsules (000#).

PQ (Performance Qualification)
PQ proves the machine consistently performs under real-world production loads.

• Example: Running three consecutive batches of different dosage forms (e.g., softgels vs. sugar-coated tablets) to ensure the counting accuracy remains 100% and the reject gate correctly diverts any miscounted bottles.

FAQ: Common Compliance Questions

Q: Can one counting machine be used for both softgels and tablets?
A: Yes, provided the machine has adjustable vibration frequencies and compatible channel widths. The SED-8S Automatic 8-Channel Electronic Counting Machine is designed with this versatility, handling everything from transparent softgels to large $000#$ capsules through its intelligent sensor array.

Q: How do I ensure my counting line is 21 CFR Part 11 compliant?
A: Look for machines with PLCs that support multi-level user access and unalterable electronic logs. The SED-8S uses a centralized control system that allows for various operating parameters to be locked, ensuring only authorized personnel can make changes to the batch settings.

Q: What is the typical footprint for a mid-speed counting line?
A: For a machine like the SED-8S, you should budget a space of approximately mm. This allows for the integrated conveyor system and the necessary clearance for operator maintenance and cleaning.

If you still have questions about various qualification certificates, please contact us immediately for one-on-one professional consultation.