Have you ever wondered what makes the top non-sterile factories in China stand out? Let’s dive into the world of pharmaceutical manufacturing to find out. From stringent GMP standards to innovative production techniques, we’ll explore what sets these factories apart and how they ensure the quality of their products.
Economy CA Non-Sterile Syringe Filter
Product Details: The Labfil® Economy CA Non-Sterile Syringe Filter is made of Cellulose Acetate (CA) material with a Polypropylene (PP) housing. It is available in 13mm, 25mm, and 33mm diameters with pore sizes of 0.22 μm and 0.45 μm. The filter is suitable for process volumes of less than 10mL (13mm), less than 100mL (25mm), and less than 150mL (33mm). It operates within a maximum temperature of 50℃, maximum pressure of 87psi, and a pH range of 4-8. Applications include chemical filtration and beverage filtration. The filters are packed in 100 pieces per plastic jar.
Pros:
– High-performance filter suitable for various labor…
– Provides reliable sample purification and separati…
– Available in different diameters and pore sizes to…
– Easy to operate with standardized design for seaml…
– Good chemical compatibility and biocompatibility.
Cons:
– Non-sterile version may not be suitable for applic…
– Maximum operating temperature is relatively low at…
– Limited pH range of 4-8, which may not be suitable…
UPDATE: Evaluating Plastic Syringes Made in China for …
Product Details: The FDA is evaluating quality and performance issues related to plastic syringes manufactured in China, which are used for injecting or withdrawing fluids from the body. The issues do not include glass syringes, pre-filled syringes, or syringes used for topical purposes. The FDA has identified problems such as leaks, breakage, and other performance failures that could affect the syringes’ ability to deliver the correct dose of medication, especially when used with other medical devices like infusion pumps.
Cons:
– Potential for device failures such as leaks and br…
– Performance issues that may affect the correct del…
– Unauthorized plastic syringes made in China have n…
– Quality system regulation violations by some distr…
– Need for immediate transition to alternative syrin…
AMN428ETS non sterile medical protective clothing data sheet
Product Details: The AMN428ETS non-sterile medical protective clothing is designed according to Chinese medical protective clothing standards. It features a non-woven fabric construction, intended for single-use applications. The clothing includes a hood, long sleeves, and elastic cuffs and hems for a secure fit. It is used in medical and healthcare settings to protect against biological fluids and other infectious materials.
Pros:
– Meets Chinese medical protective clothing standard…
– Non-woven fabric provides a barrier against biolog…
– Single-use design reduces the risk of cross-contam…
– Elastic cuffs and hems offer a secure and comforta…
Cons:
– Single-use only, which can increase costs and gene…
– Non-sterile, which may not be suitable for all med…
– Limited durability due to non-woven fabric constru…
– May not provide the same level of protection as st…
Microbial limits for non-sterile chemical drugs, API & excipient
Product Details: The guidelines released by China’s Center for Drug Evaluation (CDE) on February 17, 2023, are intended to enhance the application of quality risk management in product quality control for non-sterile chemical drugs, active pharmaceutical ingredients (API), and excipients. These guidelines standardize microbial limit standards, address issues in the current declaration process, and provide detailed information on control strategies, detection methods, and limit setting.
Pros:
– Enhances quality risk management in product qualit…
– Standardizes microbial limit testing and declarati…
– Provides clear control strategies for microbial li…
– Improves the scientific and rational development o…
Cons:
– Identifies previous issues such as lack of microbi…
– Requires pharmaceutical companies to undertake add…
– May necessitate changes in production processes an…
China Supplier High Quality Sterile Or Non-Sterile Lap Pad …
Product Details: The product is a High Quality Sterile Or Non-Sterile Lap Pad Sponge made from 100% cotton. It is designed for medical and surgical use. Key features include OEM sizes, 4/6/12 ply options, and the ability to be pre-washed or unwashed. The lap pads can be with or without X-ray detectable threads or chips and may include metal or plastic rings. Packaging options include polybags, blister packs, and medical wrapping paper. The product is certified by CE, ISO, and FDA standards. The minimum order quantity is 5000 packs, with a delivery time of 20 working days after receiving the advance payment.
Pros:
– Made from 100% cotton, ensuring high absorbency an…
– Available in both sterile and non-sterile options…
– Customizable sizes and ply options to fit various…
– Certified by CE, ISO, and FDA standards, ensuring…
– Flexible packaging options including polybags, bli…
Cons:
– Minimum order quantity of 5000 packs, which may be…
– Delivery time of 20 working days, which could be a…
FDA advises against using plastic syringes made in China
Product Details: The FDA has advised against using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co. due to potential quality and performance issues. The recommendation does not apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes. Health care providers should confirm the manufacturing location by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization.
Pros:
– Adequate supply and manufacturing capacity for pla…
Cons:
– Potential quality and performance issues with the…
– Violations related to the sale and distribution of…
BioClean™ Non Sterile Tie on Facemask MTA210-0
Product Details: The BioClean™ Non Sterile Tie on Facemask MTA210-0 offers high particle and bacterial filtration efficiency. The edges are ultrasonically sealed for a stronger bond, enhancing the mask’s durability. This mask is designed for specialized protection and is tested against ASTM standards.
Pros:
– High particle and bacterial filtration efficiency
– Edges are ultrasonically sealed for a stronger bon…
– Tested against ASTM standards for reliability
Cons:
– Non-sterile, which may not be suitable for all med…
– No specific details on the material or breathabili…
Rules for Classification of Medical Devices
Product Details: The document outlines the ‘Rules for Classification of Medical Devices’ issued by the China Food and Drug Administration. It standardizes the classification of medical devices into three classes (I, II, and III) based on their intended purposes, structural characteristics, patterns of use, and the degree of risk they pose. The classification is determined comprehensively, with higher risk devices falling into higher classes. The rules also cover the classification of medical device kits, accessories, and in-vitro diagnostic reagents.
Pros:
– Provides a clear and standardized framework for cl…
– Helps in ensuring the safety and efficacy of medic…
– Includes provisions for adjusting the classificati…
Cons:
– The complexity of the classification process may l…
– The need for continuous evaluation and adjustment…
– The rules may not fully address emerging technolog…
Non-Sterile or sterile Absorbent Cotton Gauze Lap Sponge …
Product Details: The Non-Sterile or Sterile Absorbent Cotton Gauze Lap Sponge is made from 100% natural, soft, and highly absorbent cotton. It may include an X-ray detection thread/tape and can have blue cotton loops. The product is available in pre-washed or unwashed forms. It is widely used for cleaning wounds, absorbing secretions, and other medical applications.
Pros:
– Soft and highly absorbent
– Made from 100% natural cotton
– Available in sterile and non-sterile options
– May include X-ray detection thread/tape for safety
– Optional blue cotton loops for easy identification
Cons:
– May require pre-washing if not pre-washed
– No specific antimicrobial properties mentioned
– Dependence on the presence of X-ray detection thre…
Economy PVDF Non-Sterile Syringe Filter
Product Details: Labfil® 0.45μm Economy PVDF Non-Sterile Syringe Filter is made of PVDF material with a PP housing. It is available in 13mm, 25mm, and 33mm diameters with a pore size of 0.45 μm. The effective filtration areas are 1.13cm², 4.15cm², and 5.20cm² respectively. The filter is suitable for process volumes of <10mL, <100mL, and <150mL. It has a maximum operating temperature of 100℃ and a maximum operating pressure of 87psi. Applications include chemical filtration and beverage filtration.
Pros:
– High-purity filtration effect with 0.45 micron por…
– Excellent chemical resistance due to PVDF material…
– Low resistance design allowing smooth fluid passag…
– Good mechanical properties and wear resistance, su…
– Wide range of applications including laboratory sa…
Cons:
– Non-sterile, which may not be suitable for applica…
– Limited to specific process volumes (<10mL, <100mL…
Comparison Table
| Company | Product Details | Pros | Cons | Website |
|---|---|---|---|---|
| Economy CA Non-Sterile Syringe Filter | The Labfil® Economy CA Non-Sterile Syringe Filter is made of Cellulose Acetate (CA) material with a… | – High-performance filter suitable for various labor… – Provides reliable sample purification and… | – Non-sterile version may not be suitable for applic… – Maximum operating temperature is relativel… | www.alwsci.com |
| UPDATE: Evaluating Plastic Syringes Made in China for … | The FDA is evaluating quality and performance issues related to plastic syringes manufactured in Chi… | – Potential for device failures such as leaks and br… – Performance issues that may affect the cor… | www.fda.gov | |
| AMN428ETS non sterile medical protective clothing data sheet | The AMN428ETS non-sterile medical protective clothing is designed according to Chinese medical prote… | – Meets Chinese medical protective clothing standard… – Non-woven fabric provides a barrier agains… | – Single-use only, which can increase costs and gene… – Non-sterile, which may not be suitable for… | www.lakeland.com |
| Microbial limits for non-sterile chemical drugs, API & excipient | The guidelines released by China’s Center for Drug Evaluation (CDE) on February 17, 2023, are intend… | – Enhances quality risk management in product qualit… – Standardizes microbial limit testing and d… | – Identifies previous issues such as lack of microbi… – Requires pharmaceutical companies to under… | www.cisema.com |
| China Supplier High Quality Sterile Or Non-Sterile Lap Pad … | The product is a High Quality Sterile Or Non-Sterile Lap Pad Sponge made from 100% cotton. It is des… | – Made from 100% cotton, ensuring high absorbency an… – Available in both sterile and non-sterile… | – Minimum order quantity of 5000 packs, which may be… – Delivery time of 20 working days, which co… | www.surgical-dressing.com |
| FDA advises against using plastic syringes made in China | The FDA has advised against using certain unauthorized plastic syringes made in China by Jiangsu Cai… | – Adequate supply and manufacturing capacity for pla… | – Potential quality and performance issues with the… – Violations related to the sale and distribu… | www.aha.org |
| BioClean™ Non Sterile Tie on Facemask MTA210-0 | The BioClean™ Non Sterile Tie on Facemask MTA210-0 offers high particle and bacterial filtration eff… | – High particle and bacterial filtration efficiency – Edges are ultrasonically sealed for a stronger… | – Non-sterile, which may not be suitable for all med… – No specific details on the material or bre… | www.ansell.com |
| Rules for Classification of Medical Devices | The document outlines the ‘Rules for Classification of Medical Devices’ issued by the China Food and… | – Provides a clear and standardized framework for cl… – Helps in ensuring the safety and efficacy… | – The complexity of the classification process may l… – The need for continuous evaluation and adj… | english.nmpa.gov.cn |
| Non-Sterile or sterile Absorbent Cotton Gauze Lap Sponge … | The Non-Sterile or Sterile Absorbent Cotton Gauze Lap Sponge is made from 100% natural, soft, and hi… | – Soft and highly absorbent – Made from 100% natural cotton – Available in sterile and non-sterile o… | – May require pre-washing if not pre-washed – No specific antimicrobial properties mentioned – Depen… | www.jswldmed.com |
| Economy PVDF Non-Sterile Syringe Filter | Labfil® 0.45μm Economy PVDF Non-Sterile Syringe Filter is made of PVDF material with a PP housing. I… | – High-purity filtration effect with 0.45 micron por… – Excellent chemical resistance due to PVDF… | – Non-sterile, which may not be suitable for applica… – Limited to specific process volumes (<10mL… | www.alwsci.com |
Frequently Asked Questions (FAQs)
What are the key requirements for non-sterile product manufacturing areas in China?
?
For non-sterile products, such as oral liquids, solid preparations, suppositories, and epidermal products, you need to manufacture them in areas designed as Grade D, according to the Chinese GMP guidelines. This ensures that the environment is controlled to minimize contamination risks. Dedicated air handling facilities and specific premises design are also mandatory to maintain the required environmental conditions.
How does China’s GMP regulate the training and qualification of personnel in non-sterile factories?
?
In China, the GMP rules emphasize that operators must be trained to carry out procedures correctly. This includes ensuring that all related personnel receive the required initial and continuing training, which is adapted according to need. This training is crucial to ensure that personnel can perform their duties without compromising product quality.
What are the documentation and record-keeping requirements for non-sterile product manufacturing in China?
?
You need to maintain detailed records during the entire manufacturing process, including any deviations, which must be investigated and recorded. Records of manufacture and distribution should be retained in a comprehensible and accessible form, allowing the complete history of a batch to be traced. This ensures transparency and accountability in your manufacturing process.
How does China’s GMP address the maintenance and cleanliness of premises and equipment in non-sterile factories?
?
The premises and equipment must be carefully maintained to prevent any hazards to product quality. This includes regular cleaning and disinfection according to detailed written procedures. The manufacturing environment should be neat, and repair and maintenance operations should not introduce contamination risks. Additionally, equipment calibration and maintenance are strictly regulated, with clear requirements for calibration labels and accreditation certificates.
What quality management systems and risk assessments are required for non-sterile product manufacturing in China?
?
You need to implement a robust quality management system (QMS) that includes quality risk management. This involves evaluating, controlling, and reviewing quality risks throughout the product lifecycle. The QMS should be well-established, and management representatives must report on QMS performance and identify areas for improvement. This aligns with international guidelines such as ICH Q9 and Q10, which are integrated into China’s GMP rules.
