New ASTM International Standard Supports Sampling in Pharmaceutical Manufacturing

A new ASTM International standard could help pharmaceutical manufacturers support product quality through sampling done with certain instruments.

This content was submitted directly to this website by the supplier.

Sep 28th, 2018

A new ASTM International standard could help pharmaceutical manufacturers support product quality through sampling done with certain instruments. ASTM International’s committee on manufacturing pharmaceutical and biopharmaceutical products (E55) developed the new standard (E3177), which covers both the sample from which data is taken and the sample that is taken for reference.

“This standard describes for the first time the considerations around sampling using process analytical technology, which most new pharmaceutical products rely on during development and manufacturing,” says ASTM International member Martin Warman, director, Martin Warman Consultancy Ltd. “The measurements taken directly on products or on material removed for laboratory analysis will support control and quality.”

Warman says that manufacturers could use the standard when developing and making products, while regulators could use it when reviewing documents for product approval as well as during inspections.

To purchase standards, contact ASTM International customer relations (tel +1.877.909.ASTM; sales@astm.org).

Hp 115086 Fda Stock Image 3

FDA Dec. Meeting: Drug Supply Chain Security Act Pilot Project Program

FDA will host a virtual public meeting Dec. 8 and 9, 2020.

New CDB Packaging Simplifies Product Story

D2C company simplifies and updates its packaging graphics for its CBD wellness products, as consumers seek remedies for sleep, stress reduction, and other conditions during COVID-19.

Passive Thermal Oq Guideline Cover 1

ISTA Pharma Committee: New Passive Thermal Packaging Guidance Document

ISTA releases its operational qualification (OQ) best practice guideline. Get involved: The committee needs task force members!

From top: Jeff Tucker, Tucker Company Worldwide; Kevin Lynch, Q Products and Services; Luiz Barberini, Bayer

Four Tips for Collaborating with Contract Organizations for Increased Efficiency

A Bayer supply chain expert discusses the personal side of managing CMO relationships.

Fnzkz Aoi 1280 5fb588ee677ac

Cannabis 2.0 -- Design, Engineering, Operations

Rarely does an entirely new industry emerge in packaging and processing, but the legalization of cannabis for medical and adult-use did just that.

Fewer Ampoule Rejects with Automated Inspection

Pharmaceutical manufacturer CDM Lavoisier decided to fully automate its inspection process for injectable glass ampoules, using the new AIM 3000 from Syntegon Technology.

Exhibitor Initiative Drives PACK EXPO Connects Achievement

The experience continues online through March 31, 2021

Constellation 1

Pharmaceutical Liquid Filling Monobloc with Dual-Weight Verification

BellatRx’s Constellation Monobloc is a new servo-driven fill-weigh-cap system for unstable pharmaceutical microtubes, vials, and cartridges.

Photo Courtesy: ORBIS

Four Reasons Reusable Packaging Is the Best Prescription for Pharma

The Inner Loop–blog of the Reusable Packaging Association–releases its latest article on reusable packaging in the pharmaceutical industry and how COVID-19 has affected it.

1120 Industry News 1

The Global Outlook for the Pharma Contract Packaging Market

New report predicts a 7.1% CAGR from 2020 to 2027 and highlights the countries, packaging types, and packaging materials expected to see the greatest growth.

Getty Images 685013243 5eac5bfeeff4b png

COVID-19 Vaccine: HHS Partnering with Major Pharmacy Chains

The partnership will cover approximately 60% of pharmacies throughout the U.S. states, D.C, Puerto Rico, and the U.S. Virgin Islands.

Miss PACK EXPO Connects? No Problem

The November 2020 issue of Packaging World will have landed in your mailbox about a week after the industry’s most engaging 2020 event, PACK EXPO Connects from PMMI Media Group (PMG).

The Brenton RP1000 robotic palletizer with integrated Orion MADX stretch wrapper.

Robotics Integration in End-of-Line Packaging

Showing how various modules can be integrated into a packaging line with robotic capabilities, Brenton highlighted innovations in case packing and linear servo tracks.

Pharmaworks Tf1pro Close Up Final Release Cu

Blister Machine Features Vacuum System for Reject/Transfer

In the compact TF1pro blister machine, a vacuum arm lifts ‘good’ blisters, precisely lowering them to the transfer actuator. Another key safeguard: an upper seal plate that retracts when web motion stops to prevent unnecessary heat exposure.

With Aveva Insights, users can see details showing the specific operating parameters that have been crossed by the motor, the consequences of motor failure to the line, and prescriptive actions he can take to solve the issue.

Guided Analytics Software Streamlines Equipment Maintenance

Aveva demonstrates how the guided analytics capabilities of its Insight software alerts users to performance anomalies, directs repairs, and provides deep, user-specific equipment details.

Smp Cap Lock Rfid

Cap-Lock Pharma Security Label with RFID Technology

Developed to help hospitals expand digitization initiatives, the label-and-cap security concept for prefilled syringes also enables automated inventory and supply chain management, as well as digital first-opening indication.

Brian Jeppesen, automation engineering supervisor at Omron Automation’s Technology Center, explains the Traceability 4.0 concept.

Improving Product Quality with Automated Traceability

Omron Automation demonstrates how it uses the MQTT industrial communication protocol to track work-in-process and finished goods.

Machine-centric robotics is about merging the robot controller into the machine controller so that users can manage servo control, I/O, and visualization from one industrial PC.

What Is Machine-Centric Robotics?

End users’ increasing retrofits of machines to process more SKUs is driving the integration of ABB’s robots with B&R’s control system to speed up cycle times, minimize dwell times, and eliminate extra hardware like external encoders for tracking.

Focke Side Load Case Packer 459

All-in-one Side Loading Casepacker

Machinery can handle cartons, flow packs, bags, pouches, and more.

The Vision Robot Unit, or VRU, is designed for accurate and flexible inspection of vials, syringes, cartridges, and more.

Human-Like Robotic Visual Inspection for Vials, Syringes and More

With deep learning, the Vision Robot Unit is designed to meet emerging “smart factory” needs for a fully automated, flexible inspection system that enhances control process reliability.

More in Home

The new machine platform offers complete versatility: High performance, flexible formats and functional modules, including the OPTIMA Zero L1 for feminine hygiene and light incontinence products.

Modular Platform for Healthcare Manufacturing

Optima's new Zero machine platform offers extreme flexibility in packaging for a range of products in one system, including feminine hygiene and light incontinence products.

Tyvek Roll-Feed, Cut and Seal Machine

Roll Fed Medical Sealing System Increases Speed and Integrity

Eliminating the need for individual cut lidding, the roll-fed system is also designed to reduce material costs and the risk of operator error.

The Alvey890i palletizing system from Honeywell Intelligrated analyzes real time and historic data to detect any condition that could impact performance.

Palletizer System with Built-In Analytics

The Alvey 890i series from Honeywell Inteligrated is a fully automated palletizing system that also analyzes real time and historic data to detect any performance-impacting conditions.

Aaron Donlan, product manager at Epson Robots, explains the features and capabilities of the new C12XL robot.

High-Payload, High-Reach, Lightweight 6-Axis Robot

The C12XL 6-axis robot from Epson Robots is the company’s highest payload, highest reach robot and can be used for packaging, kitting, machine tending, or palletizing.

Getty Images 1039822716

AI Deep Learning in the Pharma Market

Artificial Intelligence applied to pharma visual inspection can enhance performance and increase product integrity for the patients' safety.

General Gus Perna, who leads Operation Warp Speed, speaking to 60 Minutes.

In the News: COVID-19 Vaccine Logistics

Temperature-controlled shipping remains in the mainstream media spotlight.

Screen Shot 2020 11 11 At 10 52 29 Am

Next Gen Induction Cap Sealer is Backward Compatible

New features on the new generation include mechanically and electrically integrated stalled-bottle sensors.

The Videojet 1280 Continuous Ink-Jet Printer

Entry-Level CIJ Printer is Easy to Operate and Maintain

The 1280 CIJ printer from Videojet features all of the technologies the company is known for in an entry-level model that is simple and reliable to use, and reduces maintenance time by 95%.

A PX medical tray and a 52 pound paper lid are both recyclable, but would require two waste collection containers and processing methods. Alternatively, an HDPE tray with a Tyvek lid would be collected in the same waste receptacle and processed by the recycler in the same waste stream.

Selecting Lidding for Recyclable Medical Trays

A lid and tray are recyclable—in different waste streams? Why pairing top and bottom webs in the same recycling stream may be more efficient.

Csi Tote Tilter

Tote Tilter Provides Safe Way Maximize Product Yield

The forklift loading and unloading system can be used in a variety of industries.

Worker using Honeywell Intelligrated's TechSight to receive guided maintenance assistance.

Audio-Visual Headset for Maintenance and Repair

TechSight from Honeywell Intelligrated allows for hands-free visualization of maintenance and repair procedures with remote support.

ABB's IRB 390 has a 35% faster pick speed and 45% increase in payload (up to 15 kg), compared to ABB’s IRB 360-8/1130 FlexPicker.

Delta Robots for Packaging Line Optimization

New pick-and-place robot from ABB picks faster, handles higher payloads, and operates with software that uses digital twin technology to optimize packaging station design.