Skip to main content

Equipment Optimization

  This involves a lot more than turning up the speed.  Increasing productivity isn’t effective if machines get worn out or worse, damaged. Yet, that is what we often see.  We can help evaluate the product, environment, equipment setup and operation to maximize performance reducing downtime and changeover time. Address:   2917 E 79th St Cleveland Ohio 44104 Phone Number:   (216) 658-8038 Website URL:   http://techceuticals.com ADDITIONAL DETAILS  Hours: Mon-Fri 8:30am-5:30pm Payment Method : Cash, Cheque, Mastercard, Visa, American Express, Discover
Post a Comment

Tablet Pro — Part 7

What are GMPs and SOPs?
Good Manufacturing Practices are guidelines designed to assure consistency and reproducibility in manufacturing. GMP or cGMP; Current Good Manufacturing practices are federally regulated by the FDA. The FDA is the Food and Drug Administration. They have established a Code of Federal Regulations (CFR).
It is required by the FDA that each employee is responsible to follow and practice GMP’s. The manufacturing company can be held accountable for the employee not following the requirements of the GMP. Therefore companies have established SOP’s; Stand Operating Procedures.
Standard Operating Procedures are written instructions for the employee to follow and sign. The employee must understand that their signature assures that they have completed the SOP step by step and has not changed any step. If an employee changes a step, an explanation must be written as to why, and a deviation must be recorded by the company.
General Employee Procedures
The employee is required to follow procedures at all times. Personal hygiene; this means being physically clean (body and clothing). The employee is required to keep their hands washed, keep their body hair, nasal and oral discharge (sneezing and coughing) controlled.
Jewelry: generally not accepted to be worn in the manufacturing areas including rings, watches, brochettes, earrings including any exposed body jewelry.
Clothing: must be clean at all times. Pockets are generally not acceptable above the waste line, shirt pockets must be sewn shut.
Footwear: Street clothes and shoes should remain separate from the clothing and footwear within the manufacturing environment.
Food, drinks and medications are not allowed on the manufacturing floor. The only exception is in the case of immediate first aid requirements.
Safety
No job is worth getting hurt for. Most unit operations have some level of danger. Wet floors, cleaning chemicals, ladders, doors, fork lifts, material handling equipment, storage vessels and machinery all carry the potential for personal injury.
Always follow procedures, wear safety glasses and protective foot wear, respiratory and safe breathing apparatus when required. Remember machines don’t have a brain…use your own! Be safe and think safety at all times.
Training in Your Facility
Tablet Pro is a in-house training seminar that will provide each participant with a comprehensive knowledge of the complete tablet making process. It will provide the tools for improving tablet making skills for everyone related to the tablet making process. This includes Managers, Supervisors, R&D, QA & QC, Technical Services, Maintenance, Operators and anyone specifically involved in the tablet making process. This course will benefit everyone involved with formulation, weighing, blending, milling and all areas of powder preparation. It will also greatly benefit those involved in post compression operations such as coating, tablet printing and packaging.
This course is design to turn new & experienced tablet press attendants into “Professional Operators”. It is all about improving tablet making skills within a company is critical to the success and key to continuous quality improvement. This course will cover theory, methodology and documentation and the mindset required to meet the demands of today’s tablet making environment. We incorporate cGMP’s into all of our presentations as well as safety and proper procedure protocol. Everyone connected to the manufacturing environment must comprehend the basics of Tablet Making. Managers and Supervisors must now understand the fundamentals of making tablets, because if they do not know the basics they cannot properly support the demands of the new production environment.
We will cover Trouble shooting and root cause analysis and utilize a systematic approach to all elements of tablet making. The only way to properly fix a problem is to know “how things work”. We believe the best manufacturing facilities are the ones that have open avenues to training and exchange issues between departments. Tablet quality is the report card for all unit operations and represents the company long after it has left the manufacturing floor. The presentation is done in a lecture style classroom setting using PowerPoint. Every participant will receive a comprehensive manual and a certificate of completion. This session will be uniquely tuned for the customer.
We guarantee that this course will be both educationally beneficial and enjoyable.
Michael D Tousey, Technical Director/CEO

Labels:

Comments

Post a Comment

Popular posts from this blog

The Granulation Process 101

Basic Technologies for Tablet Making This article presents the basic technologies for preparing powders for tablet making. Granulation is the process of collecting particles together by creating bonds between them. Bonds are formed by compression or by using a binding agent. If one were to make tablets from granulated sugar versus powdered sugar, for example, powdered sugar would be difficult to compress into a tablet and granulated sugar would be easy to compress. Powdered sugar’s small particles have poor flow and compression characteristics. These small particles would have to be compressed very slowly for a long period of time to make a worthwhile tablet. Unless the powdered sugar is granulated, it could not efficiently be made into a tablet that has good tablet characteristics such as uniform content or consistent hardness. The granulation process combines one or more powders and forms a granule that will allow the tableting process to be predictable and will produce quality ta...
Post a Comment
Read more

Tablet Press Operation - Preventing and Fixing Weight and Hardness Defects: Strategies for Production Personnel

Tablet specifications are tight, and the list of possible defects is long: Variable weight, sticking, picking, black spots, streaks, capping, lamination, variable hardness, among others. This article focuses on variations in tablet weight and tablet hardness. It pinpoints the possible causes of these defects and offers advice on preventing and fixing the source of the problems. It also discusses the problems of formulations with too many fines. Every product behaves differently on a tablet press, even if it’s the same product run on a different day. The variation often stems from changes in the properties of the raw materials — active ingredients and excipients — from batch to batch. Naturally, the goal is to minimize these changes. Tablet press operators, however, don’t have any control over formulation and granulation. They have to work with what they’re given, and their employers expect them to make good tablets day in, day out. Tablet Weight: Sources of Variation Product var...
Post a Comment
Read more

Tablet Process Operation - Sticking and Picking: Some Causes and Remedies

Sticking occurs when granules attach themselves to the faces of tablet press punches. Picking is a more specific term that describes product sticking only within the letters, logos, or designs on the punch faces. This article explains the causes of sticking and picking and describes the steps you can take to resolve both problems. When a product begins sticking to the punch face, the blame game starts. Unchecked, the finger-pointing can zoom around to encompass every person with a hand in the tablet-making process. No one wants to bear the responsibility for the problem. From your colleagues in R&D you hear, “It didn’t stick to the punches in our single-station lab press. Check with the tablet press operators. They’re not running the tablet press correctly.” When you check with the tablet press operators, they say it’s a granulation problem. “If the product had been granulated correctly we wouldn’t have sticking problems.” The people in quality assurance point out that the pro...
Post a Comment
Read more