Archives November 8, 2020

What is the difference between GMP and GLP?
Both Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations are vitally related to laboratory testing. However, the two categories of regulation have notable differences, beginning with their end goal.

Good Manufacturing Practice

GMP is part of a quality system covering the manufacture and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
A Good Manufacturing Practices (GMP) Certificate can be issued by companies, which are able to document adherence to Good Manufacturing Practices, as outlined by the U.S. FDA, State Health Departments, or by another set of standards. Most countries prefer that GMP certificates be issued from a trade association, such as ACMA.

What are Good Manufacturing Practices (GMP)?

Good Manufacturing Practice (GMP)

1. Establish Good Written Procedures.
2. Qualify and Validate Processes.
3. Identify Roles and Responsibilities.
4. Keep All Records.
5. Use the Right Facilities and Equipment.
6. Assemble a Competent Team.
7. Practice Good Hygiene.
8. Maintain Facilities and Equipment.
9. Ensure Quality.
10. Use GMP Audit Checklists.

What is GMP contract manufacturing?
A GMP technical agreement ensures compliance to the current good manufacturing practices (cGMP). Need for a Technical Agreement. By defining a clear technical agreement, both parties know who will be responsible for what, thus avoiding conflicts and have defined a clear escalation route.

Is GMP the same as cGMP?
GMP is widely being used in the world when compared to CGMP. In fact, more than 100 different countries out there in the world tend to use GMP. However, only handful countries adhere to the guidelines of CGMP. GMP is widely applicable to a large number of situations out there in the world, when compared to CGMP.

What countries use GMP?
The World Health Organization version of GMP is used in over 100 other countries, mostly in the developing world. Similar GMPs are found in the EU, Australia, Canada, Japan, Singapore, and the Philippines. HACCP is used in the US, and is enforced by the FDA (for seafood and juice) and USDA (for meat).

What is a GMP lab?
GMP laboratories are laboratories that follow and systematically document adherence to Good Manufacturing Practice regulations, recognizing the importance of putting quality first and upholding production excellence at every step of the pharmaceutical manufacturing process.

Crude oil market tracking
Trend of international oil price
Last week, the average settlement price of Brent futures was $40.06/barrel, up $0.88/barrel, or 2.25%, with a range of 38.97-41.23 USD / barrel. Last week, the average settlement price of WTI futures was $37.91/barrel, up $0.41/barrel, or 1.1%, with a range of 36.81-39.15 USD / barrel.

Industry Review
Last week, the prices of petrochemical products rose in the top five, including butadiene, styrene, pure benzene, spandex 40d and PTMEG; the top five prices of PTA, PET staple, polyester FDY, LPG and MEG fell. The price of chemical products rose the top five liquid chlorine, adipic acid, crude salt, methylcyclosiloxane, hydrochloric acid; fell the top five DMF, propylene oxide, soft foam polyether, hard foam polyether, natural rubber. Last week, the price difference of DAP phosphate rock; sulfur; synthetic ammonia, MEG ethylene, adipic acid pure benzene, polypropylene propylene, styrene pure benzene; ethylene price difference increased greatly; TDI toluene; nitric acid, butyl acrylate acrylic acid; n-butanol, acrylic acid allyl, pta-px, cis-1-butadiene-butadiene were greatly reduced.
Last week, the petrochemical sector outperformed the index (1.37%), while the basic chemical sector ran low (- 0.47%).

Track and Trace Specialty Solvents Market:
This week, in domestic market, the price of pentane blends fell. At present, domestic pentane manufacturers are in the maintenance season, and the suppliers still have the right to speak, so the overall supply of goods is tight. In terms of turnover, the market sought immediate needs, and the prices of all manufacturers were steady. Normal alkanes such as n-Pentane, n-Hexane, n-Heptane and n-Octane in domestic market are volatile. Prices have risen slightly and supplies are running short. For some manufacturers, in order to maintain the old customers, they reduced the price and sold at a cut profit, and the market quotation range is still down. Considering the current alternating maintenance of domestic and foreign devices at manufacturing plants, the suppliers of each manufacturer still have the right to speak, and the overall supply of goods is still tight. Under the game between supply and demand, the market price keeps high in a short time. Please continue to pay attention to the subsequent supply policies of manufacturers and the actual transaction situation of downstream manufacturers.

The main use of hexane is as a solvent to extract edible oils from seed and vegetable crops (e.g., soybeans, peanuts, corn). (6) Commercial grades of hexane are used as solvents for glues (rubber cement, adhesives), varnishes, and inks. (3,6) Hexane is also used as a cleaning agent (degreaser) in the printing industry.

Hexane is used as the liquid in low temperature thermometers. Rubber cement is an adhesive made from elastic polymers (typically latex) mixed in a solvent such as acetone, hexane, heptane or toluene to keep them fluid enough to be used. Water-based formulas, often stabilised by ammonia, are also available. There are even paper specific rubber cements, used by paper crafters and scrapbookers worldwide!Rubber cement is an opaque liquid that contains pulverized natural or synthetic rubber and a solvent based on hexane or heptane. Grades of rubber cement may contain 70-90% heptane or hexane and 1-15% isopropyl alcohol (isopropanol) or ethyl alcohol . The rubber is received in the form of large blocks or slabs, typically 100 lb (45 kg) in size. Different grades of rubber cement may contain pulverized natural or synthetic rubber in combination with 70 percent to 90 percent heptane or hexane and 1 percent to 15 percent isopropanol or ethanol. Solvent percentage and resultant strength may or may not produce a rubber cement that can dissolve vinyl.

What is the solvent in rubber cement?
Silicone is a typical example. Rubber cement is an opaque liquid that contains pulverized natural or synthetic rubber and a solvent based on hexane or heptane. Grades of rubber cement may contain 70-90% heptane or hexane and 1-15% isopropyl alcohol (isopropanol) or ethyl alcohol (ethanol).

What is rubber adhesive?
Keeping the rubber in a solvent solution allows the rubber to remain fluid enough to be spread and used as an adhesive. These cements are considered drying adhesives, meaning that as the solvents evaporate, the “rubber” portion remains behind, ready to form a strong and flexible bonds.

What is solvent based contact adhesive?
Solvent-based contact adhesive formulations typically consist of a solvent or solvent blend, in which rubber, resin, and additives such as anti-oxidants, fillers etc. are dissolved. 

Can you use toluene solvent to remove cement?
If you are needing to remove cement that is still stuck to your surface with a solvent, you should use the same solvent that your contact cement is suspended in. Like with like. This means if you have a toluene based glue, you could apply toluene solvent to a rag and soak your dried cement to see if you can work it up that way.

The high adhesion properties of SB thermoplastic rubber-based adhesives mean that they often only have to be applied to one of the two substrates to be bonded (single spread).They generally have a high solid content that reduces the amount of adhesive required per unit of bonded surface area and the quantity of solvent emissions.
Chloroprene rubber adhesive is a solution type adhesive among widely-used rubber adhesives. It is made up of neoprene, magnesium oxide, anti-aging agent, antioxidant and filler etc., mixed and then resolved in solvent. Such adhesive has good resistance to water, oil, weak-acid, weak-alkali, aliphatic hydrocarbon and alcohols

What is chloroprene rubber adhesive?
Chloroprene rubber adhesive is a solution type adhesive among widely-used rubber adhesives. It is made up of neoprene, magnesium oxide, anti-aging agent, antioxidant and filler etc., mixed and then resolved in solvent.

Is acetone a good solvent for rubber?
Acetone is a good one on rubber, the other solvents make rubber swell. We clean the rubber gaskets on our dry time wheel with acetone, it is also easier on paint as it is a very fast evaporating solvent. I would not pur it in a bath but use a rag or paper towell.

What is rubber adhesive?
Chloroprene Rubber Adhesive (CR) Chloroprene rubber adhesive is a solution type adhesive among widely-used rubber adhesives. It is made up of neoprene, magnesium oxide, anti-aging agent, antioxidant and filler etc., mixed and then resolved in solvent.

What is rubber adhesive?
Chloroprene Rubber Adhesive (CR) Chloroprene rubber adhesive is a solution type adhesive among widely-used rubber adhesives. It is made up of neoprene, magnesium oxide, anti-aging agent, antioxidant and filler etc., mixed and then resolved in solvent.

What is rubber chemical resistance?
Use this rubber chemical resistance chart to make sure that the elastomer or O-ring seal you choose will be compatible with the particular environment. The chemical compatibility of rubber is extremely important as the rubber can degrade rapidly if the rubber material is not compatible with the environment or media that it comes into contact with.