YENCHEN MACHINERY CO., LTD. - Yenchen Machinery - leading pharmaceutical machinery manufacture in Taiwan

FAQs | Cleaning Validation - 2 | Manufacturing Equipment for Pharmaceutical Industry | Yenchen

Yenchen is a high-quality Solid Dosage Line, Pellet Machine Production Line, Syrup Line, Injection Line, Ointment Line, Extraction & Concentration Turn Key Equipments supplier from Taiwan since 1967. Yenchen was established in 1967, our products and services are widely used in the pharmaceutical, food, biotechnology, chemical, and cosmetic fields, which include solid dosage line, pellet machine production line, syrup line, injection line, ointment line, extraction & concentration turnkey equipments.

Cleaning Validation - 2 | Tablet & Sterilization Machines - Pharmaceutical Manufacturing Equipment | Yenchen

Cleaning Validation | Yenchen Machinery Co., Ltd. has been specializing in manufacturing Pharmaceutical Machine for 60 years.

Cleaning Validation

Cleaning Validation - 2

Source : Yenchen Technical Process Consultant, Dr. Fred Rowley

Types of Sampling

1. Direct Surface Sampling - Determine the type of sampling material used and its impact on the test data since the sampling material may interfere with the test. For example, the adhesive used in swabs has been found to interfere with the analysis of samples.

2. Rinse Samples - Two advantages of using rinse samples are that a larger surface area may be sampled, and inaccessible systems or ones that cannot be routinely disassembled can be sampled and evaluated. A disadvantage of rinse samples is that the residue or contaminant may not be soluble or may be physically occluded in the equipment.

Residue Limits: Testing For What?

1. Detergent or soap is used for cleaning, determine and consider the difficulty that may arise when attempting to test for residues. A common problem associated with detergent use is its composition.

2. Drug (and components)

3. 1/1,000 of a drug dose is the normal residual limit that most firms use.


If you have any technical questions, please contact with Grace Chiang Email:grace.chiang@yenchen.com.tw
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Cleaning Validation - 2 | Tablet & Sterilization Machines - Pharmaceutical Manufacturing Equipment | Yenchen

Located in Taiwan since 1967, YENCHEN MACHINERY CO., LTD. has been a pharmaceutical manufacturing equipment supplier in pharmaceutical industry. Their main manufacturing and processing equipment include, hot air sterilizers, extrusion machines, tablet coating and compression machines, pellet making machines and oral solid dosage manufacturing equipment, which are sold to over 70 countries meeting international standards.

Yenchen was established in 1967, our products and services are widely used in the pharmaceutical, food, biotechnology, chemical, and cosmetic fields, which include solid dosage line, pellet machine production line, syrup line, injection line, ointment line, extraction & concentration turnkey equipments.

Yenchen has been offering customers high-quality pharmaceutical manufacturing equipment since 1967, both with advanced technology and 57 years of experience, Yenchen ensures each customer's demands are met.